美国FDA 指导原则 根据21 CFR 320.38(C)保留的样本数量--公布--2020年8月 英文原版.pdfVIP

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Guidance for Industry This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). Submit one set of either electronic or written comments on this guidance at any time. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630