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Guidances We Develop and Enforcement Information

Contents On This Page

Regulatory & Scientific Guidances

  • Guidance Documents Web Page a searchable, topical guide to CDER guidance documents.
  • The CDER Data Standards Manual The CDER DSM is a compilation of standardized nomenclature monographs that have been reviewed and approved by the CDER Nomenclature Standards Committee (NSC).
  • Certificate of Pharmaceutical Product Acrobat Document  The Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce" was revised in 1997. As a result, CDER revised its procedures for the issuance of Certificates for Pharmaceutical Products to firms that legally market drug products.
  • Human Drug Current Good Manufacturing Practice Notes.  Human Drug Current Good Manufacturing Practice Notes is a periodic memo on Current Good Manufacturing Practice issues on human use pharmaceuticals, issued by the Division of Manufacturing and Product Quality.
  • Patent Term Extension and New Patents Docket Number *95S-0117. This file lists new and cumulative PDF Doc drug patent and exclusivity information. Effective August 18, 2003, patent submissions for publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may be downloaded from FDA Forms Download Website.
  • Pharmacology and Toxicology  Guidances for Industry
  • Suitability Petitions  List of Petitions filed under section 505(j)(2)(C) of the Food, Drug and Cosmetic Act where the Agency has determined that the referenced product: (1) Is suitable for submission as an ANDA (Petitions Approved) or (2) Is not suitable for submission as an ANDA (Petitions Denied). 

Specific Regulatory Initiatives


Submitting Applications for New Drug Products

International Activities

CDER Policies & Procedures

Compliance Activities

Freedom of Information Act

Useful Resources

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Last Updated: May 29, 2008

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