Category:Food and Drug Administration

• Food and Drug Administration
• Jeff Novitzky

A

• Abbreviated New Drug Application
• Approved Drug Products with Therapeutic Equivalence Evaluations
• User:As in liberty/Tobacco Products Scientific Advisory Committee

B

• Bad Bug Book
• Biologic License Application
• Board of Tea Appeals

C

• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health
• Center for Drug Evaluation and Research
• Center for Food Safety and Applied Nutrition
• Center for Veterinary Medicine
• The Chemical Feast
• Class I recall
• Clinical trial
• Covered clinical study
• Criticism of the Food and Drug Administration
• CSUCT
• Current Good Tissue Practices
• Cytel

D

• Defense blood standard system
• Design controls
• Drug coupon
• Drug pipeline

E

• Early history of food regulation in the United States
• Elixir sulfanilamide
• Emergency Use Authorization

F

• FDA Consumer
• FDA Fast Track Development Program
• FDA Preemption
• FDA v. Brown & Williamson Tobacco Corp.
• Federal Food, Drug, and Cosmetic Act
• Food and Drug Administration Modernization Act of 1997
• Food code
• The Food Defect Action Levels
• Form FDA 483

G

• David Graham (epidemiologist)

H

• Hazard Analysis and Critical Control Points
• Humanitarian Device Exemption

I

• Independent reviewer
• Investigational New Drug
• IVIVC

J

• JANUS clinical trial data repository
• Joshua Sharfstein

K

• Frances Oldham Kelsey

L

• List of medicine contamination incidents

M

• James Maryanski
• MedWatch
• Minor Use Animal Drug Program
• MSM blood donor controversy

N

• National Center for Toxicological Research
• National Drug Code
• Naval Ordnance Laboratory
• John Nestor
• New Drug Application

O

• Office of Criminal Investigations
• Office of Regulatory Affairs
• Orally disintegrating tablet

P

• Personalized medicine
• Pharma fraud
• Pharmaceutical drug
• Premarket approval
• Prescription Drug User Fee Act
• Product licensing application
• Pure Food and Drug Act

Q

• QSIT

R

• Radura
• Regulation of tobacco by the U.S. Food and Drug Administration

S

• SDTM
• Jeffrey Shuren

T

• Michael R. Taylor
• Title 21 CFR Part 11
• Tobacco Products Scientific Advisory Committee

U

• Unique Device Identification
• United States v. Park

V

• Vaccine Adverse Event Reporting System