Friday, July 25, 2008

FDA Guidance Documents - FDA Current Thinking (free)

Find out what the FDA is currently thinking. In these free FDA guidance documents from the FDA, you'll find out the FDA's latest position and thinking on many topics.

Here's what you can get from the FDA:

  1. Sign up for FDA Guidance Documents email updates.

  2. Guidance Documents from FDA's Centers:
    Center for Biologics Evaluation and Research
    Center for Devices and Radiological Health
    Center for Drug Evaluation and Research
    Center for Food Safety and Applied Nutrition
    Center for Veterinary Medicine
    Office of Regulatory Affairs

  3. Office of the Commissioner:
    Guidance for Industry on CGMP for Phase 1 Investigational Drugs (July 2008)
    Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing PDF [112KB] (July 2008)
    Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (February 2008)
    Emergency Use Authorization of Medical Products (July 2007)
    Exports Under the FDA Export Reform and Enhancement Act of 1996 (PDF, 233 KB)
    Computerized Systems Used in Clinical Trials [PDF] (May 10, 2007)
    Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees Draft Guidance for comment (March 2007)
    Guidance for Industry Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration Draft Guidance for comment (February 2007)
    Guidance for Industry: Advisory Committee Meetings — Preparation and Public Availability of Information Given to Advisory Committee Members Draft Guidance for comment (February 2007)
    Annual Comprehensive List of Guidance Documents (Federal Register Sept. 2, 2006)
    Early Development Considerations for Innovative Combination Products (September 2006)
    Final Guidance: Using Electronic Means to Distribute Certain Product Information (March 2006)
    Application User Fees for Combination Products (April 2005)
    Correction to Comprehensive List (PDF) (Federal Register Feb. 11, 2005)
    Conflict of Interest Disclosure Guidance (January 2002)
    Small Business Guide to FDA
    FDA Guidance -- Financial Disclosure by Clinical Investigators (March 20, 2001)
    FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 (Federal Register June 12, 1998)
    Guidance for FDA and Industry: Direct Final Rule Procedures (Federal Register Nov. 21, 1997)
    Final Guidance on Industry-Supported Scientific and Educational Activities (Federal Register Dec. 3, 1997)
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