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.
- Drug approval information (Drugs@FDA)
- Approved risk evaluation and mitigation strategies (REMS@FDA)
- Pediatric information
- Frequently requested or proactively posted drug-specific records and other records
- Warning letters and notice of violation letters
- Clinical investigator disqualification proceedings
- Frequently requested or proactively posted compliance records (Coming soon)