Vocabulary (1-100) Flashcards
Amendment to a NDA containing a safety update due 120 days after the NDA is filed.
120-day Safety Report
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 time line may be extended if FDA does not agree with the proposed protocol.
30-day hold **
A form of NDA that incorporates data without a right of reference and can rely on published literature, previously approved NDA, of “Bridging Studies” or the combination of all three. Cannot file if eligible for an ANDA. Used for new salts, dosage forms, routes of administration, etc.
505(b)(2)
i. Traditional 510(k): A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or “substantially equivalent” to a legally marketed device. 510(k) refers to the section of the Federal Food, Drug and Cosmetic Act authorizing the submission of the premarket notification.
ii. Special 510(k): For use where device modifications neither affect the intended use nor alter its fundamental scientific technology. Processing time is 30 days.
iii. Abbreviated 510(k): Submission based upon guidance document(s), special controls or standards.
510(k)
AAAS
American Association for the Advancement of Science
AABB
American Association of Blood Banks
Primarily used for generics on the 505(j) Form.
Abbreviated Antibiotic Drug Application: AADA
AAPS
American Association of Pharmaceutical Scientists
ACS
American Chemical Society
Any unexpected, unfavorable event that is may or may not be related to the use of the investigational drug.
Adverse Clinical Event: ACE
Official communication from FDA informing NDA/BLA sponsor of an agency decision. Includes approvable, not approvable, clinical hold, and warning letters.
Action Letter**
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.
Active Ingredient
ADE
Adverse Drug Event or Adverse Drug Experience
ADME of chemicals and investigational drugs is essential in measuring Pharmacokinetics.
Absorption, Distribution, Metabolism and Excretion: ADME
Any unexpected adverse drug experience not listed in the drug product’s current labeling
Adverse Drug Reaction: ADR
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 does not meet the requirements of an official compendium.
Adulterated
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment; an investigator shall promptly report to the sponsor any adverse effect that may reasonably regarded as caused by, or probably cause by the drug.
Adversent Event: AE
A database that contains information on adverse event and medication error reports submitted to FDA.
Adverse Event Reporting System: AERS
AFDO
Association of Food and Drug Officials
AHCPR
Association for Health Care Policy and Research
FDA’s approach to reviewing applications that may be affected by wrongful acts that raise significant questions regarding data reliability.
Application Integrity Policy: AIP
Additions or changes to an ANDA, NDA, PMA or PMA supplement still under review. Includes safety updates. Any updates to an IND are also called amendments.
Amendment
Used for generic animal drugs. Must reference a “listed drug”. Contains copies of literature and bioequivalence studies comparing the generic drug to the innovator drug as evidence of safety and efficacy.
Abbreviated New Animal Drug Application: ANADA
Used for generic drugs. Must reference a “listed drug”. Contains copies of literature and bioequivalence studies comparing the generic drug to the innovator drug as evidence of safety and efficacy.
- Generic vs. Listed Drug must be same:
1. onditions of use
2. ctive Ingredient
3. oute of Administration, Dosage form, and Strength
4. Labeling
Abbreviated New Drug Application: ANDA
The sections that the ANDA must include are:
- Regulatory and Administrative Requirements (I.E Paragraph Certification, Reference Listed Drug (monograph), Exclusivity Addressed, Rx to OTC status if necessary.)
- Chemistry
- Manufacturing
- Controls
- Labeling
- Testing
- Bioequivalence
ANDA Sections
An annual periodic report or progress report that must be submitted to the FDA. It must include new safety, efficacy, and labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical laboratory studies; and completed unpublished clinical trials.
Annual Report
APHIS
Animal and Plant Health Inspection Service
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product that, when used in the production of a drug, becomes an active ingredient of the medicinal product.
Active Pharmaceutical Ingredient: API**
FDA designation given to drugs, biologics and medical devices that have been granted marketing approval.
Approved
A quality standard that allows for a pre-specified number of defects. It is either a calculated or historical value that is used to determine acceptance limits for either produced or purchased goods.
Acceptable Quality Level: AQL**
ASQ
American Society for Quality (formerly ASQC)
ASR
Analyte Specific Reagents
BACPAC
Bulk Actives Chemical Post Approval Changes
Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health
Banned Devices**
BATF
Bureau of Alcohol, Tobacco, and Firearms
BIMO
Bioresearch Monitoring Program
BIO
BIO Biotechnology Industry Organization
The quality control team must inspect all documents and data to ensure that the product may be distributed before it can be released from the manufacturing plant. All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Batch Release Requirements (Drugs)
Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood componenet or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Biologic
Biologics License Application: The BLA is the licensing application for biological products and is required for CBER biological products. The BLA replaced the Product License Application (PLA) and Establishment License Application (ELA).
BLA
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”.
Blinded Study
BPCA
Best Pharmaceuticals for Children Act of 2002
CAPA
Corrective Actions and Preventive Actions
A submission to an approved application reporting changes that FDA has identified as having moderate potential to adversely affect product identity, strength, quality, purity and potency. The supplement must be received by FDA at least 30 days before product distribution.
Changes Being Effected in 30 days: CBE-30
CBE-0
Changes Being Effect in 0 days
Ensures the safety and effectiveness of biological products for the prevention and treatment of human disease.
Center for Biologics Evaluation and Research: CBER
CBP
US Customs and Border Protection
CC
Chief Counsel (FDA)
CDC
Centers for Disease Control and Prevention
Ensures the safety and effectiveness of prescription, nonprescription and generic drugs intended for human use.
Center for Drug Evaluation and Research: CDER**
Ensures the safety and effectiveness of medical devices, and protects consumers against harmful man-made radiation from medical, occupational and consumer products.
Center for Devices and Radiological Health: CDRH**
Document used to inform a potential subject of the risk and benefits of a clinical trial per the Declaration of Helsinki. Sometimes referred to as ICF (Informed Consent Form).
Consent Form: CF**
Required by certain countries to prove that exported product is being manufactured to the requirements of GMPs; provided by FDA for export of legally marketed devices.
Certificate to Foreign Government: CFG**
CFR
Code of Federal Regulations
CFSAN
Center for Food Safety and Applied Nutrition
A drug or device is deemed to be adulterated unless it is manufactured in accordance with Current Good Manufacturing Practices (cGMPs). Drug GMPs are a set of regulations that establish minimum requirements for drug product manufacturing, processing, packing, or holding methods, facilities, and controls. The intent and purpose of GMP is to ensure drugs are safe and meet quality and purity requirements.
Current Good Manufacturing Practices: cGMP (Requirements)
Low-risk device requiring general controls to ensure safety and effectiveness.
Class I Device
Requires general and special controls to ensure safety and effectiveness. Special controls may include mandatory performance standards, patient registries for implantable devices and postmarket surveillance. Requires 510(k), unless exempted; may require clinical trials.
Class II Device
Requires general controls, special controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting or pose potential risk to patient. PMAs almost always require clinical trials.
Class III Devices**
Devices that receive marketing permission, not approval. Designation is based upon demonstrating substantial equivalence to a preamendment device or another device reviewed under section 510(k) of the FD&C Act.
Clearance
FDA order to delay proposed clinical investigation or suspend an ongoing investigation.
Clinical Hold**
A medical researcher in charge of carrying out a clinical trial’s protocol.
Clinical Investigator
CMC
Chemistry, Manufacturing and Controls
CME
Continuing Medical Education
CMS
Center for Medicare and Medicaid Services
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.
Certificate of Exportability: COE
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
Commercial Distribution
Module 1: Regional Information (regarding regulatory requirements)
Module 2: Summary Information: Table of Contents, Introduction
Module 3: Quality Information (I.E. CMC information)
Module 4: Non-clinical Study reports
Module 5: Clinical Study Reports.
Common Technical Document and Sections
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.
Complaint
Any ingredient/or part intended for use in the manufacture of a drug, device, cosmetic, biologic or IVD product, including those that may not appear in the finished product.
Component
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 that such term shall not include soap.
Cosmetic
Used to code AE’s to standard preferred terms and body systems; will be replaced by MedDRA.
Coding Symbols for a Thesaurus of Adverse Reaction Terms: COSTART
CPMP
Committee for Proprietary Medicinal Products (EU)
CPSC
Consumer Product Safety Commission
A method that individuals can utilize primarily in the process that dictates the “over-the-counter” (OTC) status of a drug that was previously available only through a prescription. In this sense, citizens can directly influence the approval or review process of a drug that is eligible for OTC status. Through the conventional method, an OTC drug can be made available from a previously prescription drug by means of a NDA or an OTC monograph. This process is significant in new product development, because if a drug is eligible for OTC status, developers need to be aware that they can be delayed for approval on the market depending on how significant individuals feel on whether or not the drug should be available at any store. In fact, the citizen’s petition has become a more common experience and the FDA has received an increase in the number of petitions and as a result, several measures may be taken and amendments to the Food and Drug Administration’s Revitalization Act, enacted in 2007, to target the number of petitions and how they may delay the approval of generic drugs that are attempting to achieve OTC status as well. A citizen’s petition can also be utilized to lobby for the removal of a drug with a prescription status only, as well, thus being an effective tool that citizens can utilize to affect the course of a drug on the market. If the FDA evaluates and agrees with the petition that could mean a removal of a drug off of the market. A citizen’s petition can also be utilized in the drug approval process to allow for brand name drug manufacturer’s to keep their product on the market longer under a “brand” name thus delaying the approval of the generic or ANDA application.
Citizen’s Petition: CP
A sponsor representative that reviews the plan for the study with the site personnel to be sure that all study team members understand study procedures.
Clinical Research Associate: CRA
CRADA
Cooperative Research and Development Agreement (with NIH and FDA)
CRC
Clinical Research Coordinator
Paper or electronic document used to record data collected in a clinical trial.
Case Report Form: CRF
FDA’s effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “poof of concept” into a medical product.
Critical Path Initiative**
An organization comprised of trained individuals who are familiar and experienced with the research and developmental process. The main purpose of a CRO is to alleviate some of the tasks associated with the developmental process. A contract research organization can be utilized in each step of the research process from early discovery in conducting toxicology and dose ranging studies to develop the general toxicity of a potential drug, to clinical trials. In fact, CRO’s are instrumental in phase IV studies, because they are the individuals who are actually conducting the studies.
Contract Research Organization: CRO
Usually the FDA contact persons for sponsors. (Also known as the regulatory project manager.)
Consumer Safety Officer: CSO
An “integrated” full report of an individual study of any therapeutic, prophylactic or diagnostic agent (referred to herein as drug or treatment) conducted in patients, in which the clinical and statistical description, presentations, and analyses are integrated into a single report, incorporating tables and figures into the main text of the report, or at the end of the text, and with appendices containing the protocol, sample case report forms, investigator related information, information related to the test drugs/investigational products including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details such as derivations, computations, analyses, and computer output, etc. The integrated full report of a study should not be derived by simply joining a separate clinical and statistical report.
Clinical Study Report: CSR
Developed by the International Conference on Harmonization in effort to harmonize the organizational format of drug marketing applications for regulatory submission in the US, European Union, and Japan. Consists of 5 Modules.
i. Module 1: Regional Administrative Information
ii. Module 2: Summaries
iii. Module 3: Quality
iv. Module 4: Non-clinical Study Reports
v. Module 5: Clinical Study Reports
Common Technical Document: CTD**
CTFA
Cosmetic, Toiletry & Fragrance Association
A device that deviates from devices generally available; Deviates from an applicable performance standard or PMA requirement in order to comply with the order of a physician or dentist; Is not generally available in finished form for purchase or dispensing by prescription; Is not offered for commercial distribution through labeling or advertising, is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient; Is intended to meet the special needs of the physician or dentist.
Custom Device
(FDA) Ensures the safety and effectiveness of animal drugs, food additives, feed ingredients and animal devices for animals, humans and the environment.
Center for Veterinary Medicine: CVM**
D&D
Design and Development Plan
The division within FDA’s CDER that is responsible for enforcing all advertising and promotion laws of prescription drugs. Each center within the FDA has its own division responsible for enforcing such laws. (Now known as the OPDP – Office of Prescription Drug Promotion)
Division of Drug Marketing, Advertising, and Communications: DDMAC
DEA
Drug Enforcement Administration
An official action in accordance with 21 CFR Part 1404 to exclude a person form directly or indirectly providing services in any capacity to a firm with an approved or pending drug/device product application. A debarred corporation is prohibited form submitting or assisting in the submission any NDA or ANDA. Equivalent to disqualification for devices PMA submission.
Debarment
Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki
Declaration of Helsinki
Evaluated the effectiveness of drugs that were approved on the basis of safety alone between 1938-1962. Created Abbreviated New Drug Application (ANDA) for all DESI approved drugs rated “effective” but needing labeling changes.
Drug Efficacy Study Implementation: DESI**
i. Class I Device - Low-risk device requiring general controls to ensure safety and effectiveness.
ii. Class II Device - Requires general and special controls to ensure safety and effectiveness. Special controls may include mandatory performance standards, patient registries for implantable devices and postmarket surveillance. Requires 510(k), unless exempted; may require clinical trials.
iii. Class III Devices - Requires general controls, special controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting or pose potential risk to patient. PMA may require clinical trials
Device Classification
Describes a finished device’s design.
Design History File: DHF
DHHS
Department of Health and Human Services
Contains a device’s production history.
Device History Record: DHR
DIA
Drug Information Association
DMC
Data Monitoring Committee
