Category:Food and Drug Administration

• Food and Drug Administration

A

• Accelerated approval (FDA)
• Abbreviated New Drug Application
• Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
• Approvable letter
• Approved Drug Products with Therapeutic Equivalence Evaluations

B

• Bespoke Gene Therapy Consortium
• Biologics license application
• Biomaterials Access Assurance Act of 1998
• Blood donation restrictions on men who have sex with men
• Boxed warning

C

• Caltec Citrus Company
• Center for Biologics Evaluation and Research
• Center for Drug Evaluation and Research
• Center for Food Safety and Applied Nutrition
• Center for Tobacco Products
• Center for Veterinary Medicine
• The Chemical Feast
• Clinical trial
• Complete Response Letter
• Computerized Systems Used In Clinical Trials
• Contraceptive trials in Puerto Rico
• Criticism of the Food and Drug Administration

D

• Defense blood standard system
• Dermatologic and Ophthalmic Drugs Advisory Committee
• Design controls
• Dietary Supplement Health and Education Act of 1994
• Drug coupon
• Drug Efficacy Study Implementation
• Drug Master File
• Drug pipeline

E

• Early history of food regulation in the United States
• Ecocrop
• Electronic common technical document
• Elixir sulfanilamide
• Emergency Use Authorization

F

• Fast track (FDA)
• FDA Adverse Event Reporting System
• FDA Center for Devices and Radiological Health
• FDA citizen petition
• FDA Consumer
• FDA Food Safety Modernization Act
• FDA Most Wanted Fugitives
• FDA preemption
• FDA recall policies
• FDA v. Brown & Williamson Tobacco Corp.
• FDA warning letter
• Federal Food, Drug, and Cosmetic Act
• First-in-class medication
• Food Additives Amendment of 1958
• Food and Drug Administration Amendments Act of 2007
• Food and Drug Administration Modernization Act of 1997
• Food and Drug Administration Revitalization Act
• Food and Drug Administration Safety and Innovation Act
• Food code
• The Food Defect Action Levels
• Form FDA 483

G

• Generally recognized as safe
• Generally recognized as safe and effective
• Good tissue practice

H

• History of the Food and Drug Administration
• Humanitarian Device Exemption

I

• Independent reviewer
• Investigational New Drug
• IVIVC

J

• JANUS clinical trial data repository
• Jelly bean rule

M

• Mandatory country-of-origin labeling (US)
• Medical Device Regulation Act
• Medical device reporting
• List of medicine contamination incidents
• MedWatch
• The Mind-Benders (1967 film)
• Minor Use Animal Drug Program
• Modified risk tobacco product

N

• National Center for Toxicological Research
• National drug code
• National Milk Laboratory Certification Program
• Naval Ordnance Laboratory
• New Animal Drug Application
• New Drug Application
• No-observed-adverse-effect level

O

• Office of Criminal Investigations
• Office of Global Regulatory Operations and Policy
• Oncology Drug Advisory Committee
• Open flow microperfusion
• Orally disintegrating tablet
• Orphan Drug Act of 1983
• Over-the-Counter Hearing Aid Act of 2017

P

• PDUFA date
• Pharma fraud
• Premarket tobacco application
• Prescription Drug User Fee Act
• Priority review
• Pure Food and Drug Act

R

• Ractopamine
• Radiation Control for Health and Safety Act of 1968
• Radura
• Radurization
• Reactogenicity
• Reagan-Udall Foundation
• Regenerative Medicine Advanced Therapy
• Regulation of tobacco by the U.S. Food and Drug Administration
• Risk Evaluation and Mitigation Strategies

S

• Safe and Accurate Food Labeling Act of 2015
• Safe Medical Device Amendments of 1990
• Safeguarding Therapeutics Act
• SDTM
• Sentinel Initiative
• Shelf Life Extension Program

T

• Tea Importation Act of 1897
• Title 21 CFR Part 11
• Tobacco Products Scientific Advisory Committee

U

• Unapproved Drugs Initiative
• Unique Device Identification
• United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat's Shoo-Fly Powders for Drunkenness
• United States v. Johnson (1911)
• United States v. Park

V

• Vaccine Adverse Event Reporting System

W

• Worst-case analysis
• Curtis Wright IV

Τ

• Template:Food and Drug Administration