CDER FOIA Electronic Reading Room
The Center for Drug Evaluation and Research Freedom of Information Act (FOIA) Electronic Reading Room provides copies of CDER records (or links to other locations of CDER records) that we are making publicly available: (1) because the records are required to be published on the web by the Food, Drug and Cosmetic Act, (2) because they are “frequently requested” records under the FOIA (5 U.S.C. § 552(a)(2)(D)) or (3) proactively at our discretion. Some records may be redacted to remove non-public information. For other information about CDER’s regulatory activities, please visit the CDER home page.
To learn more about FOIA visit FDA's FOIA home page or FOIA.gov
Drug-Specific Information
- Drug approval information (Drugs@FDA)
- Approved risk evaluation and mitigation strategies (REMS@FDA)
- Pediatric information
- Additional Information on Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics REMS
- Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS
- Frequently requested or proactively posted drug-specific records and other records
Compliance Information
- Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
- Clinical investigator disqualification proceedings
- Frequently requested or proactively posted compliance records
Other Information