Guidance Formal Meetings Between the FDA and Sponsors or Applicants英语教案.pdf

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Guidance Formal Meetings Between the FDA and Sponsors or Applicants英语教案.pdf

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Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) May 2009 Procedural Revision 1 OMB Control Number 0910-0429 Expiration Date: 08/31/2012 See additional PRA statement in Section XII of this guidance (Note: PRA information added 05/04/2011) Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants Additional copies are available from: Office of Communications Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm. 2201 Silver Spring, MD 20993-0002 E-mail: druginfo@ Fax: 301-847-8714 (Tel) 301-796-3400 /cder/guidance/index.htm or Office of Communication, Outreach, and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration