美国FDA 指导原则 当前的好制造业Practice—Guidance表示目的人药组合商Facilities在部分503B的那FDC幕指导表示目的工业草稿指导表示目的工业 英文原版.pdfVIP

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FDC Act Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 commen