Current and archival drug labels, drug approval histories, and more
- Generic Drugs
Overview, patient education, approvals and reports, research and resources
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Database of all FDA approved prescription drugs, including new and generic drugs
- Drug Safety Information
Drug Safety Information and resources for healthcare professionals
- Index to Drug-Specific Information
Looking for drug safety info on a specific drug? See FDA’s Index to Drug-Specific Information.
- Medication Guides
Medication Guides are paper handouts that come with many prescription medicines. They contain FDA-approved information that can help patients avoid serious drug side effects.
- REMS: Approved Risk Evaluation and Mitigation Strategies
A drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
- Drug Recalls
FDA provides a searchable list of recalled products. Drug recalls are actions taken by a firm to remove a product from the market.
- Drug Shortages
Search the Drug Shortages Database for current and resolved drug shortages and discontinuations reported to FDA
- Drug Safety Communications
FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information.
- Medication Errors
Increase the safe use of drug products by minimizing use error related to the naming, labeling, packaging, or design of drug products regulated by FDA
- FDA Drug Info Rounds
A series of training videos for practicing clinical and community pharmacists
- Drug Safety Labeling Changes (SLC) Database Provides approved safety labeling changes from January 2016 forward
Also of Interest
- Acronyms and Abbreviations Search
Database of acronyms and abbreviations related to FDA activities
- Clinical Trials.gov
- Clinical Trials and Human Subject Protection
Information about good clinical practice and clinical trials
- Jobs at the Center for Drug Evaluation and Research (CDER)
Resources For You
- Division of Drug Information (DDI) Webinars
- Expanded Access: Information for Physicians
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
- CDERLearn Training and Education
- Hematology/Oncology (Cancer) Approvals
- What's New at FDA in HIV/AIDS
- Global Alliance of Drug Information Specialists (GADIS)