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Regulatory Affairs > Terminology Quiz 1 > Flashcards

Terminology Quiz 1 Flashcards

1
Q

120-day safety report

A

amendment to a NDA containing a safety update due 120 days after the NDA is filed

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2
Q

30-day hold

A

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

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3
Q

505(b)(2)

A

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.

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4
Q

510(k)

A

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.
ii. special 510(k): for use where device notifications neither affect the intended use nor alter its fundamental scientific technology.
iii. abbreviated 510(k): submission based upon guidance document(s), special controls or standards

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5
Q

AAAS

A

American Association for the Advancement of Science

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6
Q

AABB

A

American Association of Blood Banks

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7
Q

AADA

A

Abbreviated Antibiotic Drug Application; primarily used for generics on the 505(j) form

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8
Q

AAPS

A

American Association of Pharmaceutical Scientists

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9
Q

ACS

A

American Chemical Society

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10
Q

ACE

A

Adverse Clinical Event; any unexpected, unfavorable event that is may or may not be related to the use of the investigational drug

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11
Q

Action letter

A

official communication from FDA informing NDA/BLA sponsor of an agency decision

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12
Q

Active ingredient

A

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 others

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13
Q

ADE

A

Adverse drug event or adverse drug experience

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14
Q

ADME

A

Absorption, distribution, metabolism and excretion; essential to the measuring of pharmacokinetics

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15
Q

ADR

A

Adverse drug reaction; is any unexpected adverse drug experience not listed in the drug product’s current labeling

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16
Q

Adulterated

A

product containing any filthy, putrid or decomposed substance

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17
Q

AE

A

adverse event; any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a casual relationship with this treatment

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18
Q

AERS

A

adverse event reporting system

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19
Q

AFDO

A

Association of Food and Drug Officials

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20
Q

AHCPR

A

Association for Health Care Policy and Research

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21
Q

AIP

A

Application Integrity Policy; FDA’s approach to reviewing applications that may be affected by wrongful acts that raise significant questions regarding data reliability

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22
Q

amendment

A

additions or changes to an ANDA, NDA, PMA or PMA supplement still under review

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23
Q

ANADA

A

Abbreviated New Animal Drug Application; used for generic animal drugs

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24
Q

ANDA

A

Abbreviated New Drug Application; used for generic drugs

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25
Q

ANDA sections

A

the sections that the ANDA must include are:

  • regulatory and administrative requirements, exclusivity
  • chemistry
  • manufacturing
  • controls
  • labeling
  • testing
  • bioequivalence
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26
Q

Annual report

A

an annual periodic report or progress report that must be submitted to the FDA

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27
Q

APhA

A

American Pharmaceutical Association

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28
Q

APHIS

A

Animal and Plant Health Inspection Service

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29
Q

API

A

Active Pharmaceutical Ingredient. 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

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30
Q

Approved

A

FDA designation given to drugs, biologics and medical devices that have been granted marketing approval

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31
Q

AQL

A

Acceptable Quality Level; a quality standard that allows for a per-specified number of defects

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32
Q

ASQ

A

American Society for Quality (formerly ASQC)

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33
Q

ASR

A

Analyte Specific Reagents

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34
Q

BACPAC

A

Bulk Actives Chemical Post Approval Changes

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35
Q

Banned Devices

A

Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health

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36
Q

BATF

A

Bureau of Alcohol, Tobacco, and Firearms

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37
Q

BIMO

A

Bioresearch Monitoring Program

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38
Q

BIO

A

Biotechnology Industry Organization

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39
Q

Batch Release Requirements (Drugs)

A

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

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40
Q

Biologic

A

Any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries to man

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41
Q

BLA

A

Biologics License Application; The BLA is the licensing application for biological products and is required for CBER biological products

42
Q

Blinded Study

A

Clinical trial in which the patient (single-blind) or patient and investigator (double-blind) are unaware of which treatment the patient receives.

43
Q

BPCA

A

Best Pharmaceuticals for Children Act of 2002

44
Q

CAPA

A

Corrective Actions and Preventative Actions

45
Q

CBE-30

A

Changes Being Effected in 30 days; 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

46
Q

CBE-0

A

Changes Being Effect in 0 days

47
Q

CBER

A

Center for Biologics Evaluation and Research: ensures the safety and effectiveness of biological products for the prevention and treatment of human disease

48
Q

CBP

A

Bureau of Customs and Border Protection

49
Q

CC

A

Chief Counsel (FDA)

50
Q

CDC

A

Centers for Disease Control and Prevention

51
Q

CDER

A

Center for Drug Evaluation and Research; Ensures the safety and effectiveness of prescription, nonprescription and generic drugs intended for human use

52
Q

CDRH

A

Center for Devices and Radiological Health; ensures the safety and effectiveness of medical devices, and protects consumers against harmful man-made radiation from medical, occupational and consumer products

53
Q

CF

A

consent form; documents used to inform a potential subject of the risk and benefits of a clinical trial per the Declaration of Helinski.

54
Q

CFG

A

Certificate to Foreign Government; required by certain countries to prove that exported product is being manufactured to the requirements of GMPs

55
Q

CFR

A

Code of Federal Regulations

56
Q

CFSAN

A

Center for Food Safety and Applied Nutrition

57
Q

cGMP (requirements)

A

Current Good Manufacturing Practices; a drug of device is deemed to be adulterated unless it is manufactured in accordance with Current Good Manufacturing Practices

58
Q

Class I device

A

low-risk device requiring general controls to ensure safety and effectiveness

59
Q

Class II device

A

requires general and special controls to ensure safety and effectiveness.

60
Q

Class III device

A

requires general controls, special controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting or pose potential risk to patient

61
Q

Clearance

A

devices that receive marketing permission, not approval.

62
Q

Clinical Hold

A

FDA order to delay proposed clinical investigation or suspend an ongoing investigation

63
Q

Clinical Investigator

A

A medical researcher in charge of carrying out a clinical trial’s protocol

64
Q

CMC

A

Chemistry, Manufacturing and Controls

65
Q

CME

A

Continuing Medical Education

66
Q

CMS

A

Center for Medicare and Medicaid Services

67
Q

COE

A

Certificate of Exportability; required by certain countries for the export of unapproved devices not sold or offered for sale in the US

68
Q

Commercial Distribution

A

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, subsidairy or affiliate company or any device with an approved exemption for investigational use

69
Q

Common Technical Document and Sections

A 
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
70
Q

Complaint

A

Any written, electronic or oral communication alleging deficiences related to a product’s identity, quality, durability, reliability, safety, effectiveness, or performance after release for distribution

71
Q

Component

A

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

72
Q

Cosmetic

A

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

73
Q

COSTART

A

Coding Symbols for a Thesaurus of Adverse Reaction Terms; used to code AE’s to standard preferred terms and body systems

74
Q

CPMP

A

Committe for Proprietary Medicinal Products (EU)

75
Q

CPSC

A

Consumer Product Safety Commission

76
Q

CP

A

Citizen’s Petition: A citizen’s petition is 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

77
Q

CRA

A

Clinical Research Associate; 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

78
Q

CRADA

A

Cooperative Research and Development Agreement (with NIH and FDA)

79
Q

CRC

A

Clinical Research Coordinator

80
Q

CRF

A

Case Report Form: used to record data collected in a clinical trial

81
Q

Critical Path Initiative

A

FDA’s effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, bioloigcal product, or medical device is transformed from a discovery or “poof of concept” into a medical product

82
Q

CRO

A

Contract Research Organization; A contract research organization is an organization comprised of trained individuals who are familiar and experienced with the research and developmental process

83
Q

CSO

A

Consumer Safety Officer: usually the FDA contact persons for sponsors (also known as the project manager)

84
Q

CSR

A

Clinical study report; 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 integreated…

85
Q

CTD

A

Common technical document; developed by the international conference of 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

86
Q

CTFA

A

Cosmetic, Toiletry & Fragrance Association

87
Q

Custom Device

A

A device that deviates from devices generally available

88
Q

CVM

A

Center for Veterinary Medicine: Ensures the safety and effectiveness of animal drugs, food additives, feed ingredients and animal devices for animals, humans and the environment

89
Q

D&D

A

Design and Development Plan

90
Q

DDMAC

A

Division of Drug Marketing, Advertising and Communications; the division within FDA’s CDER that is responsible for enforcing all advertising and promotion laws of prescription drugs.

91
Q

DEA

A

Drug Enforcement Administration

92
Q

Debarment

A

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

93
Q

Declaration of Helinski

A

Ethical principles for medical research involving human subject

94
Q

DESI

A

Drug Efficacy Study Implementation: evaluated the effectiveness of drugs that were approved on the basis of safety alone between 1938-1962

95
Q

Device Classification

A

Class I device
Class II device
Class III device

96
Q

DHF

A

Design History File; describes a finished device’s design

97
Q

DHHS

A

Department of Health and Human Services

98
Q

DHR

A

Device History Record; contains a device’s production history

99
Q

DIA

A

Drug Information Association

100
Q

DMC

A

Data Monitoring Committe

Regulatory Affairs (1 decks)

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