2016 Guidance ANDA PAS under GDUFA (Final) 中英文.pdf

ANDA Submissions – Prior Approval Supplements Under GDUFA Page 1 / 20 ANDA Submissions – Prior Approval Supplements Under GDUFA Guidance for Industry 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) October 2016 Generics ANDA Submissions – Prior Approval Supplements Under GDUFA Page 2 / 20 ANDA Submissions — Prior Approval Supplements Under GDUFA Guidance for Industry Additional copies are availablefrom: Office of Communications, Division of Drug Information Centerfor Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach, and Development Centerfor Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002