美国FDA 指导原则行业180天排他性问题和解答指南英文原版.pdfVIP

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美国FDA 指导原则行业180天排他性问题和解答指南英文原版.pdf

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Guidance for Industry 180-Day Exclusivity: Questions and Answers DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 . Submit written comments to the Division of Dockets Management (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, contact (CDER) Harry Schwirck 301-796-4271; or Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm.3128, Silver Spring, MD 20993-0002, 800-835-4709 or 240-402-8010. 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) January 2017 Generic Drugs Guidance for Industry 180-Day Exclusivity: Questions and Answers Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD