美国FDA 指导原则 收集和提供FDA官方样品的702(B)部分行业指南草案 英文原版.pdfVIP

Collecting and Providing 702(b) Portions of FDA Official Samples Questions and Answers Guidance for Industry and FDA Staff DRAFT GUIDANCE This draft guidance document is for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2021-D-0593. For questions regarding this draft document contact the Office of Regulatory Affairs (ORA), Office of Strategic Planning and Operational Policy (OSPOP) at ORAPolicyStaffs@. U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Veterinary Medicine January 2022 Contains Nonbinding Recommendations Draft – Not for Implementation Collecting and Providing 702(b) Portions of FDA Official Samples Questions and Answers Guidance for Industry and FDA Staff DRAFT GUIDANCE This draft guidance document is for comment purposes only. U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs Center for Biologics