美国FDA 指导原则 受控通信和ANDA提交的附函工业指南工业指南草案 英文原版.pdfVIP

Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Dockets Management Staff (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) Nicole Park 240-402-7764. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 2021 Generics Contains Nonbinding Recommendations Draft —Not for Implementat ion Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001New Hampshire Ave., Hillandale Bldg., 4 th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@ /drugs/guidance-compliance-regu