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CBER - Compliance Programs Guidances / Guidelines / Points to Consider Information Sheets Investigational New Drug Application - Information on submitting an IND for a biological product Memoranda to Blood Establishments Rules Talkpapers These documents may also be available from one or more of the following sources: - E-Mail - Printed Copy Documents Available From CBER - Listings of Documents available from CBER. FDA - A Handbook for Requesting Information and Records from FDA - Replaces "How to Make a Freedom of Information Request", incorporating information related to the Electronic Freedom of Information Act Center for Devices and Radiological Health Guidance Pertaining to the FDA Modernization Act of 1997 - Guidance for review of devices Compilation of Laws Enforced by FDA and Related Statutes Compliance Program Guidance Manual - Office of Regulatory Affairs Compliance Policy Guides Manual - Office of Regulatory Affairs Dockets Management - Official repository for the administrative proceedings and rule-making documents for FDA FDA News and Publications - Press releases, Talk Papers and current issues of other FDA publications Federal Register documents pertaining to FDA - posted by FDA Dockets Management FDA Consumer magazine - Issues from 1989 to the present FDA Forms - Biologics - Downloadable forms (356h, 1571, 1572, 2253, 2567, 2830, 3356, 3486, etc.) Other Public Use Forms and How to Obtain Them Inspection Guides - Office of Regulatory Affairs Other Compliance Information Related Publications - Forms.Gov - The U.S. Government's Official Hub for Federal Forms Federal Register - FR Online via GPO Access Code of Federal Regulations - CFR Online via GPO Access International Conference on Harmonisation - ICH Guidelines MMWR Publications

Updated November 2, 2004

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