FDA Manuals and Publications


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FDA Manuals, Regulatory Publications, and Reports

		Advisory Committees Transcripts Annual Reports FY 2004 Annual Report Office of Management and Systems (PDF, 817 KB) Budget Reports Clinical Investigators Clinical Investigators Inspection List Disqualified/Restricted/Assurance List for Clinical Investigators Guidance for Institutional Review Boards and Clinical Investigators Notice of Initiation of Disqualification Proceedings And Opportunity to Explain (NIDPOE) Compliance Compliance Policy Guides Compliance Program Guidance Manual Debarment List Guidance Documents for Regulated Industry (incl. Comprehensive List) Regulatory Procedures Manual Warning Letters Other Compliance References Directories Public Affairs Specialists State and Local Officials FDA Employees Listing of U.S. Industries (FDA Yellow Book) Enforcement Code of Federal Regulations Enforcement Reports Laws Enforced by FDA Federal/State Relations Partnership Agreements (Office of Regulatory Affairs)				Guidance for Regulated Industry Good Guidance Practices - Final Rule (PDF 166 KB) Guidance Documents for Regulated Industry (Comprehensive List) Health Professional Information Medical Bulletin (Archive only; no longer published) Import/Export Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 (FDA Guidance for Industry) Import Alerts Import Refusal Reports Initiatives Progress and Priorities 2004 Inspections Investigations Operations Manual Other Inspection References for FDA Investigators and Inspectors Laboratories Laboratory Information Bulletins Laboratory Procedures Manual Regulatory Reform Initiatives Government Performance and Results Act -- FDA Performance Plans Unified Agenda of Federal Regulatory and Deregulatory Actions (June 2004) Research NCTR Research Accomplishments and Plans Regulatory Research Perspectives: Impact on Public Health Small Business Small Business Guide to FDA (PDF 318 KB) Small Business Representatives Staff Manual Guides User Fees--Reports to Congress Animal Drugs (ADUFA) Medical Devices (MDUFMA) Prescription Drugs (PDUFA)			Consumer Information Publications on topics of interest to the general public. More References from FDA's Centers Biologics Cosmetics Drugs Foods Medical Devices Radiological Health Toxicological Research Veterinary Medicine News Press Releases and Talk Papers Public Calendars Speeches Testimony to Congress by FDA Officials Sign Up for FDA's Free E-mail Newsletters Forms Documents in Portable Document Format (PDF) retain their original format. To view or print these documents, you must use the Adobe Acrobat Reader, which is free and available directly from Adobe's Web site with full installation instructions.

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