General FDA Information: General information
regarding each of the Centers within the FDA may be obtained by accessing the
applicable World Wide Web site.
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Center for Drug Evaluation & Research (CDER)
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Center for Biologics Evaluation & Research (CBER)
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Center for Devices & Radiological Health (CDRH)
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Center for Veterinary Medicine
(CVM)
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Center for Food Safety and Applied Nutrition (CFSAN)
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Resources Within FDA
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Freedom of Information (FOI): For more
information regarding submitting a Freedom of Information (FOI) request,
contact the FDA FOI staff at 301-827-6500.
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FDA Office of Orphan Products Development:
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FDA Office of International Affairs
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CDER Division of Over-the-Counter (OTC) Drug Products
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Glossary
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Topical Microbicides
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FDA Topical Microbicide Working Group Home Page
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Topical Microbicide Working Group Resource Listings
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External Resources - General
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Centers for Disease Control and Prevention (CDC)
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National Institutes of Health (NIH)
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National Institute of Allergy & Infectious Diseases (NIAID)
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HIV/AIDS Education & Resource Center
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National Center for HIV, STD & TB Prevention (NCHSTP/CDC)
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The Joint United Nations Program on HIV/AIDS (UNAIDS)
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National Institutes of Health, National Center for Complementary and
Alternative Medicine (NCCAM)
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External Resources - Education
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Drug Information Association (DIA)
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Pharmaceutical Education and Research Institute (PERI)
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Pharmaceutical Research and Manufacturers of America (PhRMA)
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Items of General Interest
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FDA Guidance Documents/MaPPS (CDER Manual of Policies and Procedures): For a complete list of
guidance documents or
MaPPS available from the FDA Center for Drug Evaluation and Research (CDER),
please refer to the CDER web page.
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Draft CDER Clinical/Antimicrobial Guidance Documents, including General
Considerations for Clinical Trials in Antimicrobial Development
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MaPP
6030.1 - IND Process and Review Procedures (revised June 20, 1996)
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Guidance for Industry: Content and Format of INDs for Phase I Studies of
Drugs, Including Well-characterized, Therapeutic Biotechnology-Derived Product
(November 1995)
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Preliminary Draft of Guidance for Industry: CMC Content and Format of
Investigational New Drug Applications (INDs) for Phases 2 and 3 Studies of
Drugs, Including Specified Therapeutic Biotechnology-Derived Products
(November 27, 1997)
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Federal Register: External link to the Federal Register. You may
download the Federal Register in text or Adobe Acrobat formats.
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Title 21 Code of Federal Regulations:
External link to the Code of Federal Regulations from the United States
Government Printing Office (GPO).
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FDA Forms Distribution Page: External link to
HHS/FDA forms, including Notice of Claimed Investigational Exemption for New
Drug, etc.
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IND/NDA Jackets/Submission Covers: Jackets for
Investigational New Drug (IND) applications and New Drug Applications (NTAS)
may be ordered from the United States
Government Printing Office (GPO) bookstore at 202-512-1800 or 866-512-1800,
Monday-Friday, 7:30am-5:00pm, Eastern Time (ET). Note: When ordering IND
jackets, ask for FDA Form 2675. For NDA jackets, ask for FDA Form 2626
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Drug Master File (DMF) is a submission to the Food
and Drug Administration (FDA) that may be used to provide confidential
detailed information about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of one or more human drugs.
Law or FDA regulation does not require the submission of a DMF. Further
information regarding DMF's is available in
CDER Guidance Document on Drug Master Files or
21 CFR 314.420.
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Investigational New Drug Application (IND, also
synonymous with "Notice of Claimed Investigational Exemption for a New Drug").
Further information regarding IND applications is available in
CDER Guidance Document on Content and Format of Investigational New Drug
Applications (INDs) for Phase 1 Studies of Drugs or
21 CFR 312.23
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Note: All Pre-IND interactions should be considered as
preliminary communications based on early development information, and will
generally take the form of written comments that may be supplemented by
teleconferences or meetings as needed and appropriate. Additions or
modifications to these communications may arise as additional information
becomes available, during follow-up pre-IND interactions or when an IND is
established.
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