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FDA Logo links to FDA home pageU.S. Food and Drug Administration
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

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CBER links to product areas
CBER links
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FDA Modernization Act of 1997

CBER Stakeholder Information

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Leveraging - Collaborating With Stakeholders - March 23, 2000, Stanford, CA and April 12, 2000, Durham, NC
    FR Notice - (PDF), (Text)

    FDA Information -
        - Register Online
        - Proposed Leveraging Initiatives
        - Comment Online

Development of Guidance Documents for Medical Devices Regulated by the Center for Biologics Evaluation and Research; Stakeholders Input Under FDA Modernization Act of 1997; Public Meeting and Teleconference - November 15, 1999, Bethesda, MD
    FR Notice - (PDF), (Text)

Talking With Stakeholders About FDA Modernization - April 28, 1999, Boston, MA and South San Francisco, CA
    FR Notice of Meetings and Teleconference - (PDF), (Text)
    Slide Presentation - (PPT), (Text)
    Summary of Proceedings -    April 28, 1999 - Boston, MA,   April 28, 1999 - South San Francisco, CA

Section 406(b): Communicating with Our Stakeholders - September 8, 1998, Bethesda, MD and September 14, 1998, Bethesda, MD
    FR Notice - September 8 Meeting (PDF), (Text)
    FR Notice - September 14 Meeting (PDF), (Text)

Section 406(b): Communicating with Our Stakeholders - August 14, 1998, Washington, DC and August 28, 1998, San Francisco, CA
    FR Notice - (PDF), (Text)
    Dear Colleague Letter - (PDF), (Text)
    Slide Presentation - (PPT), (Text)
    Summary of Proceedings - August 14, 1998,   August 28, 1998

 
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