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Regulatory Affairs > Terminology Quiz 1 > Flashcards

Terminology Quiz 1 Flashcards

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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
ANDA sections
the sections that the ANDA must include are: - regulatory and administrative requirements, exclusivity - chemistry - manufacturing - controls - labeling - testing - bioequivalence
26
Annual report
an annual periodic report or progress report that must be submitted to the FDA
27
APhA
American Pharmaceutical Association
28
APHIS
Animal and Plant Health Inspection Service
29
API
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
30
Approved
FDA designation given to drugs, biologics and medical devices that have been granted marketing approval
31
AQL
Acceptable Quality Level; a quality standard that allows for a per-specified number of defects
32
ASQ
American Society for Quality (formerly ASQC)
33
ASR
Analyte Specific Reagents
34
BACPAC
Bulk Actives Chemical Post Approval Changes
35
Banned Devices
Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health
36
BATF
Bureau of Alcohol, Tobacco, and Firearms
37
BIMO
Bioresearch Monitoring Program
38
BIO
Biotechnology Industry Organization
39
Batch Release Requirements (Drugs)
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
40
Biologic
Any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries to man
41
BLA
Biologics License Application; The BLA is the licensing application for biological products and is required for CBER biological products
42
Blinded Study
Clinical trial in which the patient (single-blind) or patient and investigator (double-blind) are unaware of which treatment the patient receives.
43
BPCA
Best Pharmaceuticals for Children Act of 2002
44
CAPA
Corrective Actions and Preventative Actions
45
CBE-30
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
CBE-0
Changes Being Effect in 0 days
47
CBER
Center for Biologics Evaluation and Research: ensures the safety and effectiveness of biological products for the prevention and treatment of human disease
48
CBP
Bureau of Customs and Border Protection
49
CC
Chief Counsel (FDA)
50
CDC
Centers for Disease Control and Prevention
51
CDER
Center for Drug Evaluation and Research; Ensures the safety and effectiveness of prescription, nonprescription and generic drugs intended for human use
52
CDRH
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
CF
consent form; documents used to inform a potential subject of the risk and benefits of a clinical trial per the Declaration of Helinski.
54
CFG
Certificate to Foreign Government; required by certain countries to prove that exported product is being manufactured to the requirements of GMPs
55
CFR
Code of Federal Regulations
56
CFSAN
Center for Food Safety and Applied Nutrition
57
cGMP (requirements)
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
Class I device
low-risk device requiring general controls to ensure safety and effectiveness
59
Class II device
requires general and special controls to ensure safety and effectiveness.
60
Class III device
requires general controls, special controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting or pose potential risk to patient
61
Clearance
devices that receive marketing permission, not approval.
62
Clinical Hold
FDA order to delay proposed clinical investigation or suspend an ongoing investigation
63
Clinical Investigator
A medical researcher in charge of carrying out a clinical trial's protocol
64
CMC
Chemistry, Manufacturing and Controls
65
CME
Continuing Medical Education
66
CMS
Center for Medicare and Medicaid Services
67
COE
Certificate of Exportability; required by certain countries for the export of unapproved devices not sold or offered for sale in the US
68
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, subsidairy or affiliate company or any device with an approved exemption for investigational use
69
Common Technical Document and Sections
``` 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
Complaint
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
Component
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
Cosmetic
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
COSTART
Coding Symbols for a Thesaurus of Adverse Reaction Terms; used to code AE's to standard preferred terms and body systems
74
CPMP
Committe for Proprietary Medicinal Products (EU)
75
CPSC
Consumer Product Safety Commission
76
CP
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
CRA
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
CRADA
Cooperative Research and Development Agreement (with NIH and FDA)
79
CRC
Clinical Research Coordinator
80
CRF
Case Report Form: used to record data collected in a clinical trial
81
Critical Path Initiative
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
CRO
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
CSO
Consumer Safety Officer: usually the FDA contact persons for sponsors (also known as the project manager)
84
CSR
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
CTD
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
CTFA
Cosmetic, Toiletry & Fragrance Association
87
Custom Device
A device that deviates from devices generally available
88
CVM
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
D&D
Design and Development Plan
90
DDMAC
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
DEA
Drug Enforcement Administration
92
Debarment
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
Declaration of Helinski
Ethical principles for medical research involving human subject
94
DESI
Drug Efficacy Study Implementation: evaluated the effectiveness of drugs that were approved on the basis of safety alone between 1938-1962
95
Device Classification
Class I device Class II device Class III device
96
DHF
Design History File; describes a finished device's design
97
DHHS
Department of Health and Human Services
98
DHR
Device History Record; contains a device's production history
99
DIA
Drug Information Association
100
DMC
Data Monitoring Committe

Regulatory Affairs (1 decks)

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