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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
(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 (6/22/2004) and cumulative
(2/6/2004)
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 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
Legislation
Submitting Applications for New Drug Products
International Activities
CDER Policies & Procedures
Compliance Activities
Freedom of Information Act
Useful Resources
- Narcotic Treatment Program
Directory
(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.
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.
[Accessibility]
FDA/Center for Drug Evaluation and Research
Last Updated: September 20, 2004
Originator: OTCOM/DML
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