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        Guidance, Compliance, & Regulatory Information

CDER FOIA Electronic Reading Room Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          CDER FOIA Electronic Reading RoomGuidance, Compliance, & Regulatory Information CDER FOIA Electronic Reading Room
  	
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    PrintThe 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 recordsCompliance Information

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
	Clinical investigator disqualification proceedings
	Frequently requested or proactively posted compliance recordsOther Information

Advisory Committee meeting information

                                                                                  Content current as of:
      08/05/2019CDER FOIA Electronic Reading Room
 
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