U.S. Food and Drug Administration Center for Drug Evaluation and ResearchSkip navigation

CDER - Center for Drug Evaluation and Research Logo

Regulatory Information

CDER HomeSite InformationComments and FeedbackWhat's NewCDER Navigation Bar

CDER ArchivesSpecific AudiencesCDER CalendarRegulatory InformationDrug InformationAbout CDERSide Navigational Buttons

Guidances We Develop and Enforcement Information

Regulatory & Scientific Guidances

  • Guidance Documents Web Page a searchable, topical guide to CDER guidance documents.
  • The CDER Data Standards Manual (Updated 2/5/2001).  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 (Issued 9/1997, Posted 9/26/1997, Updated 7/2002).  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 PDF Doc (7/29/2003) and cumulative PDF Doc (2/10/2003) drug patent and exclusivity information. A patent submission sample format has been made available in HTML or PDF format.(4/25/2000)
  • Pharmacology and Toxicology  Includes guidances, internal procedures, and contact information.
  • 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

  • Narcotic Treatment Program Directory Adobe Acrobat Document (2/9/2000).  Narcotic Treatment Programs Directory is a listing of all outpatient maintenance/detoxification programs, and all inpatient detoxification programs approved by the Food and Drug Administration for the treatment of narcotic addiction using narcotic drugs. Methadone and LAAM are the only narcotic drugs which have been approved for use in the treatment of narcotic addiction. The Directory is a valuable source for those individuals seeking treatment and for those medical professionals referring patients to treatment. The Directory will be updated quarterly.

PDF Doc Some of documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with full installation instructions. Get Adobe Acrobat


FDA/Center for Drug Evaluation and Research
Last Updated: July 7, 2003
Originator: OTCOM/DML