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Additional Resources Regarding Drug Development

General FDA Information: General information regarding each of the Centers within the FDA may be obtained by accessing the applicable World Wide Web site.





Center for Drug Evaluation & Research (CDER)



Center for Biologics Evaluation & Research (CBER)



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Center for Food Safety and Applied Nutrition (CFSAN)




Resources Within FDA



Freedom of Information (FOI): For more information regarding submitting a Freedom of Information (FOI) request, contact the FDA FOI staff at 301-827-6500.



FDA Office of Orphan Products Development:



FDA Office of International Affairs



CDER Division of Over-the-Counter (OTC) Drug Products





Topical Microbicides



FDA Topical Microbicide Working Group Home Page



Topical Microbicide Working Group Resource Listings




External Resources - General



Centers for Disease Control and Prevention (CDC)



National Institutes of Health (NIH)



National Institute of Allergy & Infectious Diseases (NIAID)



HIV/AIDS Education & Resource Center



National Center for HIV, STD & TB Prevention (NCHSTP/CDC)



The Joint United Nations Program on HIV/AIDS (UNAIDS)



National Institutes of Health, National Center for Complementary and Alternative Medicine (NCCAM)




External Resources - Education



Drug Information Association (DIA)



Pharmaceutical Education and Research Institute (PERI)



Pharmaceutical Research and Manufacturers of America (PhRMA)




Items of General Interest





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.




Draft CDER Clinical/Antimicrobial Guidance Documents, including General Considerations for Clinical Trials in Antimicrobial Development




MaPP 6030.1 - IND Process and Review Procedures (revised June 20, 1996)





Guidance for Industry: Content and Format of INDs for Phase I Studies of Drugs, Including Well-characterized, Therapeutic Biotechnology-Derived Product (November 1995)




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)





Federal Register: External link to the Federal Register. You may download the Federal Register in text or Adobe Acrobat formats.





Title 21 Code of Federal Regulations: External link to the Code of Federal Regulations from the United States Government Printing Office (GPO).





FDA Forms Distribution Page: External link to HHS/FDA forms, including Notice of Claimed Investigational Exemption for New Drug, etc.








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




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.





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





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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FDA/Center for Drug Evaluation and Research
Last Updated: November 17, 2004
Originator: OTCOM/DML