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FDA/CDER/MCCRAYK
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Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators Guidance for Industry DRAFT GUIDANCEThis guidance document is being di stributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Manage ment (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document c ontact (CDER) Amalia Himaya at 301-796-0700 or (CBER) the Office of Communication, Outreach , and Development at 800-835-4709 or 240-402 -7800. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evalua tion and Research (CBER)May 2015 Procedural 8061dft.doc 04/29/15
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