Information about the Products We Regulate
Contents On This Page
New Prescription Drug Approvals
Prescription Drug Information
Drug Information Pathfinder
- Drug Information Pathfinder. Provides
links to information on specific drugs, drug development, drug application process, drug
imports, and other topics.
Major Drug Information Pages
For information on specific drugs, please see the
Index to Drug-Specific Information.
- Antidepressant Use in Children, Adolescents, and
- COX-2 Selective and
Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Counter Terrorism Drugs
(includes calcium-DTPA and zince-DTPA, cipro, doxycycline, levaquin, prussian blue,
penicillin G procaine, and pyridostigmine bromide)
- Estrogen and Estrogen
with Progestin Therapies for Postmenopausal Women
- Exocrine Pancreatic Insufficiency Drug
- "Fen-Phen" Information (fenfluramine,
- Influenza (Flu) Antiviral Drugs
- Levothyroxine Sodium Product Information
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Pain Relievers (analgesics) and Fever Reducers
- Sleep Disorder (sedative-hypnotics) Drug Products
- Rheumatology Therapeutics
Consumer Drug Information
Over-the-Counter Drug Information
Drug Safety & Side Effects
Drug Preparedness and Bioterrorism Response
Clinical Trials Information
Public Health Alerts & Warning Letters
Reports & Publications
- Drug Safety Newsletter This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
- Drug Master Files
Drug Master Files (DMFs) are submissions to the FDA containing
confidential manufacturing information about drugs, packaging materials,
and excipients. The DMF lists are updated quarterly. The site
also contains information about filing DMFs.
- Drug Registration and Listing System
Instruction Booklet The Drug Listing Act of 1972, amending the
Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. Its purpose is to
provide the Commissioner of the FDA a current list of all drugs manufactured,
prepared, propagated, compounded, or processed by a drug establishment registered under the
Federal Food, Drug, and Cosmetic Act.
- Evaluation of Written
Prescription Information Provided in Community Pharmacies, 2001
FDA Consumer Special
Issue - From Test Tube to Patient.
This article describes the drug approval process from a consumer perspective.
Special Projects & Programs
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Last Updated: January 22, 2009