美国FDA 指导原则 四氢生物蝶呤缺乏症患者口服5-HTP类药物的即刻依从性政策 英文原版.pdfVIP

Contains Nonbinding Recommendations Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to . 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 document contact Tracy Rupp (CDER) at tracy.rupp@. 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 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) July 2019 Compounding 1 Contains No