US Glossary Flashcards
21st Century Cures Act (CCA)
Amends various FD&C Act and PHS Act sections to include provisions for:
• patient-focused drug development
• advancing new drug therapies
• modern trial design and evidence development
• patient access to therapies and information
• antimicrobial innovation and stewardship
• medical device innovations
• improving FDA scientific expertise and outreach
• medical countermeasures innovation
• vaccine access, certainty and innovation
30-day hold
Time period between filing a protocol under an IND and FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (See “Clinical Hold.”)
120-day Safety Report
Amendment to an NDA containing a safety update due 120 days after the NDA is filed.
180-day Exclusivity
Protects an ANDA applicant from competition from subsequent generic versions of the same drug product for 180 days.
505(b)(2) Application
An application submitted under FD&C Act Section 505(b) (2) for a drug for which one or more of the investigations relied on by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C. 355(b)(2)).
510(k)
Traditional 510(k): A premarket notification submitted to FDA to demonstrate the medical device to be marketed is as safe and effective or “substantially equivalent” to a legally marketed device. 510(k) refers to the FD&C Act section authorizing the submission of the premarket notification. • Special 510(k): A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. • Abbreviated 510(k): A type of 510(k) submission supported by conformance with guidance document(s), special controls or standards.
513(g) Request for Information
When it is unclear into which classification a device falls, a provision in FD&C Act Section 513(g) allows the device sponsor to request a classification determination and regulatory information from FDA. This requires a letter with a description of the device and a fee payment.
515 Program Initiative
Created to facilitate reclassification action on the remaining pre-amendments Class III 510(k)s.
AABB
American Association of Blood Banks
ACBTSA
Advisory Committee on Blood and Tissue Safety and
Availability
Accelerated Approval
Allows earlier approval of drugs to treat serious diseases and those filling an unmet medical need based on a surrogate endpoint.
Accredited Persons Program
FDA program accrediting third parties to conduct the primary 510(k) review for eligible devices.
ACE
Adverse Clinical Event
ACRP
Association for Clinical Research Professionals
ACT
Applicable Clinical Trial
Action Letter
Official communication from FDA informing an NDA or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold.
Active Ingredient
Any drug component intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or other animals.
ADE
Adverse Drug Event or Adverse Drug Experience
ADME
Absorption, Distribution, Metabolism and Excretion
ADR
Adverse Drug Reaction
ADUFA
Animal Drug User Fee Act of 2003
ADUFA II
Animal Drug User Fee Amendments of 2008
ADUFA III
Animal Drug User Fee Amendments of 2013
Adulterated
Product containing any filthy, putrid or decomposed
substance; or prepared under unsanitary conditions; or
not made according to GMPs; or containing an unsafe
color additive; or not meeting the requirements of an
official compendium (FD&C Act, Section 501 [351]).
AdvaMed
Advanced Medical Technology Association
Advisory Committee
Committees and panels used by FDA to obtain independent expert advice on scientific, technical and policy matters.
AE
Adverse Event
AFDO
Association of Food and Drug Officials
AGDUFA
Animal Generic Drug User Fee Act of 2008
AGDUFA II
Animal Generic Drug User Fee Act of 2013
AHRQ
Agency for Healthcare Research and Quality
AIA
America Invents Act of 2011
AIP
Application Integrity Policy—FDA’s approach to
reviewing applications that may be affected by wrongful acts raising significant questions regarding data reliability.
ALCOA
Attributable, legible, contemporaneous, original and
accurate — Acronym used by FDA to describe data quality.
AMDUCA
Animal Medicinal Drug Use Clarification Act of 1994
Amendment
Additions or changes to an ANDA, NDA, BLA, PMA
or PMA supplement still under review. Includes safety
updates. Any updates to an IND or an IDE prior to
approval also are called amendments.
AMS
Agricultural Marketing Service (USDA)
ANADA
Abbreviated New Animal Drug Application
Analyte
In a clinical trial, the part of the sample the test is designed to find or measure.
ANDA
Abbreviated New Drug Application—Used for generic drugs.
Animal Drugs@FDA
Database allowing users to search for approved animal drug products, suitability petitions, sponsors, the Green Book, CFR, FR, patents and exclusivity.
Animal Rule
Provides for approval of certain new drug and biological products based on animal data when adequate and well controlled efficacy studies in humans cannot be conducted ethically because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers and field trials are not feasible prior to approval.
Anti-Kickback Statute
Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal healthcare program business.
Annual Report
An annual periodic report or progress report required to be submitted to FDA. Depending on the type of application for which the report is submitted, it may include new safety, efficacy and labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical laboratory
studies; and completed unpublished clinical trials.
ANPR
Advance Notice of Proposed Rulemaking
APhA
American Pharmacists Association
APHIS
Animal and Plant Health Inspection Service
API
Active Pharmaceutical Ingredient
APLB
Advertising and Promotional Labeling Branch (CBER)
Approved
FDA designation given to drugs, biologics and medical devices granted marketing approval.
AQL
Acceptable Quality Level
ASTM
American Society of Testing and Materials
ASQ
American Society for Quality (formerly ASQC)
ASR
Analyte Specific Reagent
ATF
Bureau of Alcohol, Tobacco, Firearms and Explosives
AUT
Actual Use Trials
BA/BE Studies
Bioavailability and bioequivalence studies.
Bad Ad Program
Truthful Prescription Drug Advertising and Promotion—
Education program for healthcare providers to ensure prescription drug advertising and promotion are truthful and not misleading. Administered by CDER’s Office of Prescription Drug Promotion (OPDP).
Banned Device
Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health.
BIMO
Bioresearch Monitoring Program
BIO
Biotechnology Industry Organization
Bioequivalence
The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the
same molar dose under similar conditions in an appropriately designed study.
Biologic
A virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the prevention, treatment or cure of a disease or condition of human beings.
Biosimilar
Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show, among other things, the product is “highly similar” to an already-approved biological product.
Bioterrorism Act
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
BLA
Biologics License Application
Blinded Study
Clinical trial in which the patient (single-blind) or patient and investigator (double-blind) are unaware of which treatment the patient receives. Involves use of multiple treatment groups such as other active, placebo or alternate dose groups. Sometimes referred to as “masked.”
Boxed Warning
Drugs with special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information.
This often is referred to as a “boxed” or “black box” warning. Drugs with such boxed warnings are not permitted to have reminder advertisements.
BPCA
Best Pharmaceuticals for Children Act of 2002
BPCI Act
Biologics Price Competition and Innovation Act of 2009
BPDR
Biological Product Deviation Report
Breakthrough Therapy Designation
A new pathway to expedite the development of therapies showing substantial promise in early clinical trials. A drug company may seek Breakthrough Therapy designation if the drug is developed for a serious and life-threatening disease
and preliminary clinical evidence shows the drug may offer substantial improvement over existing therapies on one or more clinically significant endpoints.
BsUFA
Biosimilar User Fee Act
CAPA
Corrective and Preventive Actions
CBE-30
Changes Being Effected in 30 days—A submission to an approved application reporting changes FDA has identified as having moderate potential to affect drug product identity, strength, quality, purity and potency adversely. The supplement must be received by FDA at least 30 days before product distribution.
CBER
Center for Biologics Evaluation and Research
CBP
US Customs and Border Protection
CDC
Centers for Disease Control and Prevention
CDER
Center for Drug Evaluation and Research
CDRH
Center for Devices and Radiological Health
CDx
Companion Diagnostic
CF
Consent Form—Document used to inform a potential
subject of a clinical trial’s risks and benefits per the
Declaration of Helsinki. Sometimes referred to as ICF
(Informed Consent Form) or ICD (Informed Consent
Document).
CFG
Certificate to Foreign Government—Required by certain countries to prove an exported product can be legally marketed in the US.
CFR
Code of Federal Regulations
CFSAN
Center for Food Safety and Applied Nutrition
CGMP
Current Good Manufacturing Practice
CGT Products
Cellular and gene therapy products
CGTP
Current Good Tissue Practice
CH
Clinical Hold
CHPA
Consumer Healthcare Products Association
CIOMS
Council for International Organizations of Medical Sciences
CIP
Clinical Investigation Plan
CIR
Cosmetic Ingredient Review
Class I Device
Low-risk device requiring general controls to ensure safety and effectiveness.
Class II Device
Requires general and special controls to ensure safety and effectiveness. Special controls may include guidance documents, mandatory performance standards, patient registries for implantable devices and postmarket surveillance.
Requires a 510(k), unless exempted; may require clinical trials.
Class III Device
Requires general controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting, pose significant potential for risk to patient, or are not substantially equivalent to Class I or Class II devices. PMAs almost always require clinical trials.
Clearance
Devices that receive marketing permission through the 510(k) process based on demonstrating substantial equivalence to a pre-amendment device or another device reviewed under FD&C Act Section 510(k).
CLIA
Clinical Laboratory Improvement Amendments of 1988
Clinical Hold
FDA order to delay proposed clinical investigation or
suspend an ongoing investigation.
Clinical Investigator
A medical researcher in charge of carrying out a clinical trial protocol.
ClinicalTrials.gov
A registry and results database of federally and privately supported clinical trials conducted in the US and around the world. Operated by NIH.
CLSI
Clinical and Laboratory Standards Institute (formerly
National Committee for Clinical Laboratory Standards)
CMC
Chemistry, Manufacturing, and Controls
CME
Continuing Medical Education
CMS
Centers for Medicare & Medicaid Services
COA
Clinical outcomes assessment—Directly or indirectly
measures how patients feel or function and can be used to determine whether a drug has been demonstrated to provide a treatment benefit.
Codex Alimentarius Commission
Develops harmonized international food standards, guidelines and codes of practice to protect the health of consumers and ensure fair practices in the food trade.
COE
Certificate of Exportability—Required by certain countries for the export of unapproved devices not sold or offered for sale in the US; issued by FDA to the exporter.
COFS
Certificate of Free Sale—Issued for food products regulated by FDA’s Center for Food Safety and Applied Nutrition; issued online as downloadable PDFs.
Combination Product
Defined in 21 CFR 3.2(e) as a combination of two or
more different types of regulated products, i.e.:
• a drug and a device
• a device and a biological product
• a drug and a biological product
• a drug, a device and a biological product
Commercial Distribution
Any distribution of a device intended for human use, which is offered for sale but does not include internal or interplant transfer within the same parent, subsidiary or affiliate company or any device with an approved exemption for investigational use.
Common Rule
Requires the research institution’s IRB to ensure each research protocol contains adequate provisions to protect a subject during the course of the study.
Companion Diagnostic
An in vitro diagnostic device or an imaging tool providing information essential for the safe and effective use of a corresponding therapeutic product.
Complaint
Any written, electronic or oral communication alleging deficiencies related to a product’s identity, quality, durability, reliability, safety, effectiveness or performance after release for distribution.
Component
Any ingredient or part intended for use in the manufacture of a drug, device, cosmetic, biologic or IVD product, including those not appearing in the finished product.
Consent Decree
Enforcement action carried out by the Department of
Justice. An agreement between FDA and a company outlining steps to correct CGMP violations by placing severe restrictions on company operations to ensure the firm comes into compliance.
COOL
Country of Origin Labeling—Requirements for source
labeling for food products (USDA).
Cosmetics
Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering appearance; and, articles intended for use as a component of any such article; except such term
shall not include soap.
CPG
Compliance Policy Guide
CPGM
Compliance Program Guidance Manual
CPI
Critical Path Initiative
CPSC
Consumer Product Safety Commission
CRA
Clinical Research Associate
CRC
Clinical Research Coordinator
CRF
Case Report Form—Paper or electronic document used to record data collected in a clinical trial.
Critical Path Initiative
FDA’s effort to stimulate and facilitate a national move to modernize the scientific process through which a potential human drug, biological product or medical device is transformed from a discovery or “proof of concept” into a medical product.
CR Letter
Complete response letter—Communicates FDA’s decision to a drug company its new drug application (NDA) or abbreviated new drug application (ANDA) to market a new or generic drug will not be approved in its present form.
CRO
Contract Research Organization
CSO
Consumer Safety Officer—Often the FDA contact
person for sponsors. Also known as the regulatory project manager.
CTD
Common Technical Document
CTFA
Cosmetic, Toiletry and Fragrance Association
CTP
Center for Tobacco Products
Custom Device
A device:
• deviating from devices generally available
• deviating from an applicable performance standard
or PMA requirement to comply with the order of a
physician or dentist
• not generally available in finished form for purchase or dispensing by prescription
• not offered for commercial distribution through
labeling or advertising, intended for use by an individual patient named in the order of a physician or dentist, and made in a specific form for that patient
• intended to meet the special needs of the physician or dentist
CVB
Center for Veterinary Biologics (USDA)
CVM
Center for Veterinary Medicine (FDA)
DARRTS
Document Archiving, Reporting and Regulatory Tracking System (CDER)
DDT
Drug Development Tools
DEA
Drug Enforcement Administration
Dear Health Care Professional (DHCP) letter
Correspondence mailed by a manufacturer and/or distributor to physicians and/or other healthcare professionals to convey important information about drugs or devices. DHCP letters are considered promotional labeling and may be associated with recalls or device corrections or removals. These letters can be requested by FDA or initiated by the applicant.
Debarment
An official action in accordance with 21 CFR 1404 to
exclude a person from directly or indirectly providing services in any capacity to a firm with an approved or pending drug or device product application. A debarred corporation is prohibited from submitting or assisting in the submission of any NDA or ANDA. Equivalent to disqualification for devices requiring a PMA submission.
Declaration of Helsinki
Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice (GCP) generally follow the Declaration of Helsinki.
Default Decree
A court order entered when a seized article is not claimed or defended. The order condemns the article as being in violation of the law and provides for its destruction, donation to charity, sale or disposal as the court may elect to decree.
De Novo Process
Provides a route to market for low- to moderate-risk medical devices that have been classified in Class III because FDA has found them to be “not substantially equivalent” (NSE) to legally marketed predicate devices.
DESI
Drug Efficacy Study Implementation
DFUF
Device Facility User Fee
DHF
Design History File—Describes a finished device’s design.
DHR
Device History Record—Contains a device’s production history.
DIA
Drug Information Association
Discipline Review Letter
Used by FDA to convey early thoughts on possible deficiencies found by a discipline review team for its portion of the pending application at the conclusion of the discipline review.
DMC
Data Monitoring Committee
DMEPA
Division of Medication Error Prevention and Analysis
CDER
DMF
Drug Master File—Submission to FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.
DMPQ
Division of Manufacturing and Product Quality (CBER)
DMR
Device Master Record—Compilation of records containing a finished device’s procedures and specifications
DNCE
Division of Nonprescription Clinical Evaluation
DRC
Direct Recall Classification Program (CBER)
DRISK
Division of Risk Management (CDER)
DRLS
Drug Registration and Listing System
Drug
Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.
Drugs@FDA
A searchable database of brand-name and generic prescription and OTC human drugs and biological therapeutic products approved since 1939.
“Drug Facts” Label
Labeling requirement for all nonprescription, over-the-counter (OTC) medicine labels with detailed usage and warning information so consumers can choose and use the products properly.
Drug Product
A finished dosage form (e.g., tablet, capsule, solution, etc.) containing an active drug ingredient. It generally, but not necessarily, also is associated with inactive ingredients. This includes a finished dosage form not containing an active ingredient but intended to be used as a placebo.
DQSA
Drug Quality and Security Act. Also called the
Compounding Quality Act.
DSB
Drug Safety Oversight Board (CDER)
DSCSA
Drug Supply Chain Security Act
DSHEA
Dietary Supplement Health and Education Act of 1994
DSNDCA
Dietary Supplement and Nonprescription Drug Consumer Protection Act
DTC
Direct-to-Consumer (advertising)
D-U-N-S
Data Universal Numbering System—A unique nine-digit sequence provided by Dun & Bradstreet that is specific to each physical location of an entity (e.g., branch, division and headquarters).
EA
Environmental Assessment
EAP
Expedited Access Pathway Program—A voluntary program for certain medical devices demonstrating the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions and subject to PMAs or de novo requests.
eBPDR
Electronic Biological Product Deviation Reports
EC
European Commission, European Community or Ethics
Committee
ECO
Emergency Change Order
eCopy (CDRH)
Required format for medical device submissions to FDA. eCopy is an exact duplicate of the paper submission, created and submitted on a CD, DVD or flash drive. The eCopy application must pass certain technical standards before it will be accepted by FDA for review.
eCTD
Electronic Common Technical Document
eDRLS
Electronic Drug Registration and Listing System
EFTA
European Free Trade Association
EIR
Establishment Inspection Report
EMA
European Medicines Agency
eMDR
Electronic Medical Device Reporting requirement for
manufacturers and importers to submit MDRs to FDA in an electronic format FDA can process, review and archive. The two options for submitting eMDRs are eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR).
Emergency Use IND
FDA authorization for shipping a drug for a specific emergency use for a life-threatening or serious disease for which there is no alternative treatment.
EPA
Environmental Protection Agency
ERS
Expedited Review Status program for veterinary products.
Establishment Listing and Registration
In accordance with 21 CFR 807, manufacturers (both
domestic and foreign) and initial distributors (importers) of medical devices must register their establishments electronically with FDA. Manufacturers must also list their devices with FDA.
eSubmitter
Under the eMDR program, a free downloadable application allowing submission of MDRs one at a time. This option is suitable for low volume reporters.
ETASU
Elements to Ensure Safe Use
EU
European Union has 28 Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK. EU policies also apply to members of the European Free Trade Association: Iceland, Norway, Switzerland and Liechtenstein.
Excipient
An ingredient contained in a drug formulation that is not a medicinally active constituent.
Expected Life
Time a device is expected to remain functional after being placed into service.
Expiration Date
Date printed on product label indicating the end of the product’s useful life. Expiration period length is determined by stability studies and negotiated with FDA.
FAERS
FDA Adverse Event Reporting System—A database containing information on adverse event and medication error reports submitted to FDA (CDER).
FALCPA
Food Allergen Labeling and Consumer Protection Act of 2004
FAR
Field Alert Report
Fast Track
FDA program to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions demonstrating the potential to address unmet medical needs. Accelerated NDA review.
FCA
False Claims Act
FCC
Federal Communications Commission
FD&C Act
Federal Food, Drug, and Cosmetic Act of 1938
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act of 2007
FDA ESG
FDA Electronic Submissions Gateway—Enables the secure submission of regulatory information for review.
FDAMA
FDA Modernization Act of 1997
FDASIA
Food and Drug Administration Safety and Innovation Act of 2012
FDLI
Food and Drug Law Institute
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
FOIA
Freedom of Information Act
FPI
Full prescribing information
FPLA
Fair Packaging and Labeling Act
FR
Federal Register
FSIS
Food Safety and Inspection Service
FSMA
Food Safety Modernization Act of 2011
FSMP
Food for special medical purposes
FTC
Federal Trade Commission
FURLS
FDA Unified Registration and Listing System for establishment registration of medical device operators and distributors.
GADPTRA
Generic Animal Drug and Patent Term Restoration Act of 1988
GAIN Act
Generating Antibiotic Incentives Now Act of 2011
GAO
Government Accountability Office
GCP
Good Clinical Practice—Regulations and requirements with which clinical studies must comply. These regulations apply to manufacturers, sponsors, clinical investigators and Institutional Review Boards.
GDUFA
Generic Drug User Fee Amendments
GE
Genetically engineered
Generic Drug
Drugs manufactured and approved after the original brand-name drug has lost patent protection. Sponsor files an Abbreviated New Drug Application (ANDA) for marketing approval.
GLP
Good Laboratory Practice—Regulations governing the
conduct of nonclinical laboratory studies supporting or
intended to support research or marketing applications.
GMP
Good Manufacturing Practices (for devices, see Quality
System Regulation)
GPO
Government Printing Office and Group Purchasing
Organization
GPR
General Purpose Reagents
Grandfathered
Tacit approval of drugs marketed before 1938 and devices marketed before May 1976.
GRAS(E)
Generally Recognized as Safe (and Effective)
Green Book
FDA-published listing of all animal drug products approved for safety and effectiveness. Updated monthly.
Group Purchasing Organization (GPO)
An entity consisting of two or more hospitals or other healthcare entities formed to offer its members access to purchasing contracts for health supplies (i.e., pharmaceuticals, biologics, medical/surgical equipment, laboratory supplies and other capital equipment).
GRP
Good Review Practice or Global Regulatory Plan
GTP
Good Tissue Practice
Guidance
Documents published by FDA to provide current
interpretation of regulations.
HAACP
Hazard Analysis and Critical Control Point (inspection
technique)
Hatch-Waxman Act
Drug Price Competition and Patent Restoration Act of 1984
HCT/P
Human Cells, Tissues and Cellular and Tissue-Based
Products
HDE
Humanitarian Device Exemption
HeartNet
A subnetwork of MedSun (CDRH’s adverse event reporting program) focusing on identifying, understanding and solving problems with medical devices used in electrophysiology laboratories.
HEAT
Health Care Fraud Prevention and Enforcement Action
Team
HHS
Department of Health and Human Services
HIPAA
Health Insurance Portability and Accountability Act of 1996, also known as the Privacy Rule, established the minimum federal requirements for protecting the privacy of individually identifiable health information.
HMO
Health Maintenance Organization
Homeopathic Drug
Any drug labeled as being homeopathic listed in the
Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it or its supplements. Homeopathy is based on the belief disease symptoms can be cured by small doses of
substances producing similar symptoms in healthy people.
HPC-C
Hematopoietic progenitor cells derived from cord blood.
HPCUS
Homeopathic Pharmacopoeia Convention of the United States
HPUS
Homoeopathic Pharmacopoeia of the United States
HTA
Health Technology Assessment
HUD
Humanitarian Use Device
Human Factors
The study or evaluation of how people use technology, specifically the interaction of human abilities, expectations and limitations with work environments and system design.
IB
Investigator’s Brochure
IC (ICF) (ICD)
Informed Consent (Form) (Document)
ICA
Intercenter Agreement
ICCBBA
International Council for Commonality in Blood Banking Automation
ICCR
International Cooperation on Cosmetic Regulations
ICH
Founded in 1990, the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use develops guidelines intended to simplify the multi-region marketing approval application process for pharmaceutical and biologic manufacturers.
Member regulatory bodies include the European
Commission, Japan’s Ministry of Health, Labour and
Welfare and Pharmaceuticals and Medical Devices Agency, the US FDA, Health Canada and Swissmedic. Additional agencies hold membership or observership status. In 2015, the organization reorganized and changed its name to the
International Council on Harmonisation.
ICSR
Individual case safety report
IDE
Investigational Device Exemption
IDMC
Independent Data Monitoring Committee
IMDRF
International Medical Device Regulators Forum—A voluntary group of medical device regulators from around the world who have come together to build on the foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international
medical device regulatory harmonization and convergence.
Immunogenicity
The ability of a substance to provoke an immune response or the degree to which it provokes a response.
Inactive Ingredient
Any drug product component other than the active ingredient, such as excipients, vehicles and binders.
INAD
Investigational New Animal Drug (application)
INCI
International Nomenclature of Cosmetic Ingredients
IND
Investigational New Drug (application)
Information Amendment
Includes most submissions under an active IND, such as new protocols, final study reports, safety reports, CMC information, etc. The initial IND ends with 000; each serial amendment receives the next consecutive number.
INN
International Nonproprietary Names
Intended Use
Objective labeled use of a device.
Investigator IND
Protocol and IND submitted by an individual investigator instead of a manufacturer. A letter of authorization allows FDA to review the sponsor’s DMF or cross-reference CMC information. The investigator, not the manufacturer, is responsible for maintaining the IND.
IOM
Investigations Operations Manual or Institute of Medicine
IRB
Institutional Review Board or Independent Review Board
IR Letter
A communication FDA sends to an applicant during an application or supplement review to request further information or clarification needed or helpful in completing the discipline review.
ISO
International Organization for Standardization
IUO
Investigational Use Only
IVD
In Vitro Diagnostic
JINAD
Generic Investigational New Animal Drug
KidNet
A subnetwork of MedSun (CDRH’s adverse event reporting program) focusing on identifying, understanding and solving problems with medical devices used in neonatal and pediatric intensive care units.
Label
Any display of written, printed or graphic matter on the immediate container or package of, or affixed to, any article.
Labeling
All written, printed or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment in interstate commerce; includes user manuals, brochures, advertising, etc.
LDT
Laboratory developed test—A subset of in vitro diagnostic devices designed, manufactured and offered for clinical use by a single laboratory.
LOA
Letter of Authorization—A letter from a Drug Master File holder to FDA authorizing another party to reference the DMF (also Letter of Agreement).
LoD
Limit of Detection
Lookback Procedure
Donor screening procedure used by blood establishments to retrieve and quarantine units previously collected from a donor who originally tested negative for HIV or another infectious disease but subsequently tested positive at a later donation.
Major Statement
Refers to the presentation in a television or radio advertisement of a prescription drug’s most important risks. This presentation must be spoken. It also can be included in the video part of television advertisements.
Market Withdrawal
Firm-initiated removal or correction of a device, drug or biologic product involving a minor violation of the FD&C Act, not subject to legal action by FDA, or involving no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.
MAF
Device Master File—Analogous to a Drug Master File, this submission to FDA may be used to provide confidential detailed information about a medical device or a component used in the manufacture of a medical device to FDA in support of another party’s obligation.
MAPP
Manual of Policies and Procedures—Approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.
MAUDE
Manufacturer and User Facility Device Experience database (CDRH)—Contains reports of adverse events involving medical devices.
MCB
Master Cell Bank—A collection of cells of uniform composition derived from a single source prepared under defined culture conditions.
MCSR
Minor changes and stability report (for animal drugs)—A report submitted to the application annually within 60 days before or after the application’s original approval anniversary date or a mutually agreed upon date.
MDR
Medical Device Reporting
MDSAP
Medical Device Single Audit Program—Pilot program
allowing FDA and other international partners to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory
authorities participating in the pilot program. FDA
will accept the MDSAP audit reports as a substitute for routine agency inspections.
MDUFA III
Medical Device User Fee Amendments of 2012
MDUFMA
Medical Device User Fee and Modernization Act of 2002
MedDRA
Medical Dictionary for Regulatory Activities—Global
standard international medical terminology designed to supersede or replace all other terminologies used within the medical product development process including COSTART and WHO-ART.
Medical Device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory:
• recognized in the official National Formulary or US
Pharmacopeia, or any supplement to them
• intended for use in diagnosis of disease or other
conditions, or in cure, mitigation, treatment or prevention of disease in man or other animals intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and which is not dependent upon being metabolized for the achievement of its primary intended purposes (FD&C Act Section 201(h))
Medical Food
A food formulated to be consumed or administered enterally under the supervision of a physician and intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
Medication Guide
Paper handouts accompanying many prescription medicines, addressing issues specific to particular drugs and drug classes, containing FDA-approved information to help patients avoid serious adverse events.
MedSun
Medical Product Safety Network—An adverse event reporting program for healthcare professionals launched in 2002 by CDRH.
MedWatch
FDA program for voluntary and mandatory reporting of AEs and product problems (Form FDA 3500 or 3500A).
Misbranded
Designation given to an incorrectly labeled product (i.e., false or misleading or fails to include information required by law). Other violations also may render a product misbranded (e.g., failure to obtain a 510(k) for a device).
MMA
Medicare Prescription Drug, Improvement and Modernization Act of 2003
Modular PMA
Allows a company to file completed PMA portions or
modules for an ongoing FDA review.
MOU
Memorandum of Understanding—An agreement between FDA and another country’s regulatory authority allowing mutual recognition of inspections.
MTD
Maximum Tolerated Dose
MUMS
Minor Use and Minor Species Animal Health Act of 2004
NADA
New Animal Drug Application
NAF
Notice of Adverse Findings
NAFTA
North American Free Trade Agreement
NAI
No Action Indicated—Most favorable FDA post-inspection classification.
NCE
New Chemical Entity
NCTR
National Center for Toxicological Research
NDA
New Drug Application
NDA Number
A six-digit number assigned by FDA to each application for new drug marketing approval in the US. A drug can have more than one application number if it has different dosage forms or routes of administration.
NDA Field Alert
Report filed with FDA within three working days of obtaining information on any distributed drug product with contamination, significant chemical or physical change, deterioration, batch failure or labeling causing mistaken identity.
NDC
National Drug Code—The first five digits identify establishment and last five digits identify drug name, package size and drug type.
Next-Generation Sequencing
Technologies that parallelize the genetic sequencing process, allowing the production of thousands or millions of sequences concurrently (also referred to as “high-throughput sequencing”).
NF
National Formulary (incorporated into the USP-NF)
NIDPOE
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letter
NIH
National Institutes of Health
NLEA
Nutrition Labeling and Education Act of 1990
NLM
National Library of Medicine
NME
New Molecular Entity
NORD
National Organization for Rare Disorders
NOV
Notice of Violation letter
NRC
National Research Council or Nuclear Regulatory
Commission
NSE
Not Substantially Equivalent—Designation for a device not qualifying for 510(k) clearance; generally requires a PMA.
NSR
Nonsignificant Risk
Nuremberg Code of 1947
A set of research ethics principles for human experimentation created as a result of atrocities involving medical experimentation on humans during World War II.
OAI
Official Action Indicated—Serious FDA post-inspection classification.
OBRR
Office of Blood Research and Review (CBER)
OC
Office of the Commissioner (FDA)
OCBQ
Office of Compliance and Biologics Quality (CBER)
OCC
Office of the Chief Counsel (FDA)
OCE
Oncology Center of Excellence
OCET
Office of Counterterrorism and Emerging Threats (FDA)
OCI
Office of Criminal Investigation (FDA)
OCP
Office of Combination Products (FDA)
OCTGT
Office of Cellular, Tissue and Gene Therapies (CBER)
ODA
Orphan Drug Act of 1983
ODE
Office of Device Evaluation (FDA)
OECD
Organization for Economic Cooperation and
Development
Off-Label Drug Use
When a drug is used in a way different from that described in the FDA-approved drug label.
Office of the Chief Scientist
Includes the following offices:
• Office of Counterterrorism and Emerging Threats
• Office of Regulatory Science and Innovation
• Office of Scientific Integrity
• Office of Scientific Professional Development
• FDA’s National Center for Toxicological Research
OFM
Office of Financial Management (FDA)
OGD
Office of Generic Drug Products (CDER)
OIG
Office of the Inspector General (FDA)
OIP
Office of International Programs (FDA)
OIR
Office of In Vitro Diagnostics and Radiological Health (formerly the Office of In Vitro Diagnostic Device Evaluation and Safety)
OIRA
Office of Information and Regulatory Affairs (OMB)
ONADE
Office of New Animal Drug Evaluation (CVM)
OND
Office of New Drugs (CDER)
ONDQA
Office of New Drug Quality Assessment (CDER)
ONPLDS
Office of Nutritional Products, Labeling and Dietary
Supplements (CFSAN)
OOPD
Office of Orphan Products Development (FDA)
OPA
Office of Public Affairs (FDA)
OPDP
Office of Prescription Drug Promotion (CDER)
Open Label Study
A clinical trial in which subjects and investigators are aware of the treatment received.
ORA
Office of Regulatory Affairs (FDA); oversees FDA’s field organization.
Orange Book
FDA-published listing of Approved Drug Products with Therapeutic Equivalence Evaluations generally known as generics (original print version had an orange cover).
Orphan Drug
Drugs for a disease or condition affecting fewer than
200,000 persons in the US or occurring in more than 200,000 but for which there is no reasonable expectation the drug development and manufacturing costs will be recovered from US Sales.
OSB
Office of Surveillance and Biometrics (CDRH)
OSHA
Occupational Safety Health Administration
OSI
Office of Scientific Integrity (FDA)
OTC
Over-the-Counter—Nonprescription drugs receive this designation.
OTC Monograph
Rules for a number of OTC drug categories.
OVRR
Office of Vaccine Research and Review (CBER)
PADER
Periodic Adverse Drug Experiences Report
PAI
Preapproval Inspection
PAS
Prior Approval Supplement or Postapproval Study
PAT
Process Analytical Technology
PBRER
Periodic benefit-risk evaluation reports
PCPC
Personal Care Products Council (formerly Cosmetic,
Toiletry and Fragrance Association)
PD
Pharmacodynamics—Study of the reactions between
drugs and living structures.
PDA
Parenteral Drug Association
PDMA
Prescription Drug Marketing Act of 1987
PDP
Product Development Protocol (for medical devices) or
Principal Display Panel (for product labels)
PDUFA
Prescription Drug User Fee Act of 1992
PDUFA II
Prescription Drug User Fee Act of 1997
PDUFA III
Prescription Drug User Fee Act of 2002
PDUFA IV
Prescription Drug User Fee Act of 2007
PDUFA V
Prescription Drug User Fee Act of 2012
Pediatric Rule
Requires manufacturers to assess the safety and effectiveness of certain drug and biological products in pediatric patients.
PEPFAR
President’s Emergency Plan for AIDS Relief
Personalized Medicine
Tailoring medical treatment to a patient’s individual characteristics, needs and preferences during all stages of care, including prevention, diagnosis, treatment and follow-up.
PGx
Pharmacogenomics—The study of DNA and RNA characteristics’ variations to drug response.
Pharmaceutical Equivalents
Drug products containing the same active ingredient(s), same dosage form and route of administration and identical in strength or concentration.
Pharmacovigilance
Adverse event monitoring and reporting
PhRMA
Pharmaceutical Research and Manufacturers of America
Phase I
Initial clinical safety studies in humans. May be as few
as 10 subjects, often healthy volunteers, includes PK,
ADME and dose escalation studies. Usually open label.
Phase II
Well-controlled clinical trials of approximately 100–300 subjects who have the condition of interest, includes PK, dose ranging, safety and efficacy.
Phase III
Larger, well-controlled clinical trials of hundreds to thousands of subjects, including both safety and efficacy data. Generally, two well-controlled studies are needed to establish a drug product’s efficacy.
Phase IV
Postmarket clinical trials performed to support labeling and advertising or fulfill FDA safety requirements noted at the time of NDA approval.
PHI
Protected Health Information
PHS
Public Health Service
PHS Act
Public Health Service Act
PI
Package Insert (approved product labeling) or Principal Investigator
PK
Pharmacokinetics—The study of the chemicals and medicines’ ADME processes.
Placebo
A drug product fashioned to look like an active drug but containing no active ingredient. Used in clinical trials to blind or mask the patient, investigator or both as to the treatment received.
PLR
Physician Labeling Rule
PMA
Premarket Approval—Marketing application required for Class III devices.
• Traditional PMA—The complete PMA application
is submitted to FDA at one time.
• Modular—The complete contents of a PMA are
broken down into well-delineated components (or
modules) and submitted to FDA as soon as the
applicant has completed the module, compiling a
complete PMA over time.
• Streamlined—A pilot program in the Division of
Clinical Laboratory Devices. A complete PMA is
submitted as in a traditional PMA; however, the
Streamlined PMA is for a device in which the technology and use are well known to FDA.
• Product Development Process (PDP)—The clinical
evaluation of a device and the development of necessary information for marketing approval are merged into one regulatory mechanism. Ideal candidates for the PDP process are those devices in which the technology is well established in industry.
PMC
Postmarketing commitment—Studies or clinical trials a sponsor has agreed to conduct but not required by a statute or regulation.
PMN
Premarket Notification—A premarket notification is also called a 510(k).
PMOA
Primary Mode of Action—A combination product’s single mode of action providing its most important therapeutic action; used to assign a combination product to a lead FDA center.
PMR
Postmarketing Requirements—Studies and clinical trials sponsors are required to conduct under one or more statutes or regulations.
PMS
Postmarketing Surveillance—Ongoing monitoring of
approved medical products’ safety; may include Phase IV studies and AE reporting.
PPA
Poison Prevention Act
PPACA
Patient Protection and Affordable Care Act of 2010
PPI
Patient Package Insert—Contains information explaining how patients should use a drug product safely.
PPI
Patient preference information—Qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions.
PPIA
Poultry Products Inspection Act
PREA
Pediatric Research Equity Act of 2003
Preclinical Studies
Animal PK and toxicity studies generally performed prior to clinical studies. These studies must comply with GLP.
Pre-Sub Meeting
Provides the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or device marketing application.
Priority Review
FDA review category for drugs appearing to represent an advance over available therapy. Designated NDAs or BLAs receive faster review than standard applications.
PRO
Patient-reported outcome
Protocol
Document describing a clinical trial’s objectives, design and methods. All GLP and GCP studies must follow a protocol.
PSUR
Periodic Safety Update Report
PTC
Points to Consider—Type of guidance published by FDA, usually CBER.
PTCC
Pharmacology/Toxicology Coordinating Committee
CDER
PTE
Patent term extension
PTO
Patent and Trademark Office
Public Health Security and Bioterrorism Preparedness
and Response Act of 2002
Also known as the Bioterrorism Act
PWR
Pediatric Written Request—BPCA authorizes FDA (in consultation with NIH) to issue a written request for pediatric studies to holders of approved NDAs and ANDAs for drugs on the NIH list.
QA
Quality Assurance
QAU
Quality Assurance Unit
QC
Quality Control
QbR
Question-based review (CDER)—Chemistry,
Manufacturing, and Controls (CMC) evaluation of ANDAs incorporating the most important scientific and regulatory review questions focused on critical pharmaceutical attributes essential for ensuring generic drug product quality.
QbD
Quality by Design—This concept emphasizes building
quality into a product with a thorough understanding
of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.
QIDP
Qualified Infectious Disease Product
QoL
Quality of Life
QSIT
Quality System Inspection Technique
QSR
Quality System Regulation (21 CFR 820)—Identifies
GMPs for medical devices.
R&D
Research and Development
RAC
Reviewer Affairs Committee (CDER) or Regulatory Affairs
Certification
RAPS
Regulatory Affairs Professionals Society
Rare Pediatric Disease Priority Review Voucher
A voucher FDA issues to a rare pediatric disease product
application sponsor at the time of marketing application
approval. This voucher entitles the holder to designate a
single human drug application submitted under FD&C Act
Section 505(b)(1) or PHS Act Section 351 as qualifying for
a priority review.
RCDAD
Relevant communicable disease agents and diseases
RCT
Randomized Clinical Trial or Randomized Controlled Trial
Real-Time PMA Supplement
A supplement to an approved premarket application or
premarket report under Section 515 requesting a minor
change to the device, such as a minor change to the device design, software, sterilization or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the supplement’s status.
Recall
A firm’s removal or correction of a marketed product FDA
considers to be in violation of the laws it administers and
against which the agency would initiate legal action, e.g.,
seizure. Recall does not include a market withdrawal or a
stock recovery.
Recall Classification
Assigned by FDA and applicable to firm-initiated device
recalls based on reasonable probability and relative degree of health hazard.
• Class I—violative device would cause serious adverse
health consequences
• Class II—violative device may cause temporary or
medically reversible adverse health consequences or
such consequences are remote
• Class III—violative device is not likely to cause
adverse health consequences
Reference Product
The single biological product licensed under PHS Act Section 351(a) against which a biological product is evaluated in an application submitted under subsection 351(k).
Regenerative Medicine
A group of medicinal products comprising cell therapy, gene therapy and tissue engineering.
Regulation
Refers to Code of Federal Regulations
REMS
Risk Evaluation and Mitigation Strategies
Restricted Device
A device restricted by regulation to sale, distribution and/
or use only upon the written or oral authorization of a
licensed practitioner or other conditions prescribed by the
commissioner.
RFA
Request for Application
RFD
Request for Designation—A written submission to the
Office of Combination Products (OCP) requesting designation of the center with primary jurisdiction for a
combination or non-combination product.
RFR (Request for Reconsideration)
Request for Reconsideration—A request for OCP to reconsider an RFD determination.
RFR (Reportable Food Registry)
Reportable Food Registry—An electronic portal used to
report foods suspected of causing serious adverse health consequences.
RiskMAP
Risk Minimization Action Plan—A strategic safety program designed to meet specific goals and objectives in minimizing a product’s known risks while preserving its benefits.
RLD
Reference Listed Drug—Drug product listed in the
Approved Drug Products with Therapeutic Equivalence
Evaluations book (also known as the Orange Book).
Rolling NDA Submission
Allows a company to file the completed portions of an NDA for ongoing FDA review. Permitted only for drugs and biologics FDA has granted Fast Track designation.
RPM
Regulatory Procedures Manual—A reference manual for
FDA personnel containing information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
RTA Policy
Refuse to accept—FDA will conduct an acceptance review of all traditional, special or abbreviated 510(k)s and PMAs based on objective criteria using the applicable Acceptance Checklist to ensure the 510(k) or PMA is administratively complete.
RTF
Refusal to File—Letter sent by FDA when an incomplete
NDA or ANDA is filed. FDA will not review the application until complete. Letter is sent within 60 days of submission.
RUO
Research Use Only
Rx
Prescription Use Only
Rx-to-OTC Switch
The process of transferring FDA-approved prescription
medications to nonprescription, over-the-counter (OTC)
products for the same dosage form, population and route
of administration.
SAE
Serious Adverse Event
SAHCODHA
Severe adverse health consequence or death in humans or animals
SBA
Summary Basis of Approval
SC
Study Coordinator
SDWA
Safe Drinking Water Act
SE
Substantially Equivalent
S&E
Safety and Efficacy
SECG
Small entity compliance guide
Sentinel Initiative
Program FDA has in place aimed at developing and implementing a proactive system to complement existing systems to track reports of adverse events linked to the use of its regulated products.
SGE
Special government employee
Shelf Life
Maximum time a device will remain functional from the
date of manufacture until it is used in patient care (See
Expiration Date).
Significant Risk Device
An investigational device:
• intended as an implant
• represented to be for use in supporting or sustaining
human life
• for a use of substantial importance in diagnosing,
curing, mitigating or treating disease or otherwise
preventing impairment of human health and
presents a potential for serious risk to the subject’s
health, safety or welfare
SMDA
Safe Medical Devices Act of 1990
SoCRA
Society of Clinical Research Associates
SOP
Standard Operating Procedure
Source Documents
Original documents and records containing information
captured in a clinical study. Case Report Forms are
monitored against source documents. Includes office charts, laboratory results, x-rays, etc.
SPA
Special Protocol Assessment
SPL
Structured Product Label. Content of package insert in
XML format.
SR
Significant Risk (device)
Sponsor
Company, person, organization or institution taking
responsibility for initiating, managing or financing a clinical trial or a product marketing application.
SSED
Summary of Safety and Effectiveness Data—An FDA document intended to present a reasoned, objective and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.
SST
Safety Signal Tracking
Standard Review (S)
FDA review category for drugs with therapeutic qualities
similar to those already approved for marketing.
Subject
Clinical trial participant; may be a healthy volunteer or a
patient.
Subpart E
21 CFR 312—Accelerated review for life-threatening and
severely debilitating illness.
Subpart H
21 CFR 314.500—Approval based upon a surrogate
endpoint or a product approved with restrictions and/or
requirements for Phase IV trials.
Substantial Equivalence
Comparison of a new device to a legally marketed predicate device; substantial equivalence establishes a device is as safe and as effective as another 510(k)-cleared device.
Suitability Petition
A request to FDA to submit an ANDA for a product varying from a Reference Listed Drug in indication, strength, dosage form, route of administration, etc.
SUPAC
Scale Up and Post-Approval Changes
Supplement (sNDA)
NDA submission for changes to an approved NDA, including SUPAC.
Supplement (sPMA)
PMA submission for changes to an approved PMA that
affect the device’s safety or effectiveness.
Surrogate Endpoint
A laboratory or physical sign used in trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions or survives and is expected to predict the therapy’s effect.
Target Product Profile (TPP)
A format for a drug development program summary
described in terms of labeling concepts. A TPP can be
prepared by a sponsor and shared with the appropriate
FDA review staff to facilitate communication regarding a
particular drug development program.
TEA
Time and extent application—Demonstrates a drug product can meet the statutory standard of marketing to a material extent and for a material time.
Team Biologics
A group of specialized investigators who conduct routine
and CGMP follow-up inspections of biological product
manufacturers regulated by CBER. Partnership program
between ORA and CBER.
TFM
Tentative Final Monograph
Therapeutic Equivalence
Drug products that are otherwise safe and effective and can be expected to have equivalent therapeutic effect and equivalent potential for adverse effects when used under the conditions set forth in their labeling.
Third-party Review
Under FDAMA, FDA has accredited third parties authorized to conduct the primary review of 510(k)s for eligible devices.
THOMAS
Public federal legislation database (Library of Congress)
TK
Toxicokinetics
Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act of 2009
TOPRA
The Organisation for Professionals in Regulatory Affairs
TPLC
Total product lifecycle
TPP
Target Product Profile
Transitional Device
Devices regulated as drugs prior to 28 May 1976, when
the Medical Device Amendments were signed into law. Any device approved by the New Drug Application process now is governed by the PMA regulations.
Treatment IND (tIND)
Allows limited use of an unapproved drug for patients with a serious or life-threatening disease.
TSCA
Toxic Substances Control Act
TTB
Tax and Trade Bureau
UADE
Unexpected Adverse Device Effect—Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not identified previously in nature, severity or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device relating to the rights, safety or welfare of subjects.
UDI
Unique Device Identification—Requires a device’s label to
bear a unique identifier, unless an alternative location is
specified by FDA or an exception is made for a particular
device or group of devices.
Unexpected AE
An AE, the nature or severity of which is not described in the Investigator’s Brochure (for an unapproved product) or in the package insert (for an approved product).
USAN
US Adopted Name
USANC
US Adopted Names Council
USC
US Code
USCA
US Code Annotated
USDA
US Department of Agriculture
User Fees
Fees authorized by Congress to fund various FDA activities.
The fee schedule for different application types is published annually in the Federal Register. Initially established by the Prescription Drug User Fee Act and later extended to medical devices, generic drugs and animal drugs.
USP
United States Pharmacopeia
VA
Department of Veterans Affairs
VAERS
Vaccine Adverse Event Reporting System
VAI
Voluntary Action Indicated—Moderately serious FDA
post-inspection classification.
VCRP
Voluntary Cosmetic Registration Program—FDA postmarket reporting system for use by manufacturers, packers and distributors of cosmetic products in US commercial distribution.
VICH
Veterinary International Conference on Harmonization
VSTA
Virus-Serum-Toxin Act
Warning Letter (WL)
Serious enforcement letter issued by FDA notifying a regulated entity of violative activity; requires action within 15 days.
Warning Letter Database
Contains Warning Letters issued from November 1996 to
present, searchable by company, subject, issuing office or
date.
WCB
Working Cell Bank—Cells derived from one or more vials of cells from the master cell bank, which are expanded by serial subculture.
Well-Characterized Biologic
A biological product whose identity, purity, impurities,
potency and quantity can be determined and controlled.
WHO
World Health Organization
Yates Memo
A memo issued by deputy attorney general Sally Quillian Yates that amended the False Claims Act, limiting any discretionary credit the government would provide violators to only those who would reveal the responsible parties at all levels of an organization.
