美国FDA 指导原则 第505(B)(2)条涵盖的应用 英文原版.pdfVIP

Guidance for Industry Applications Covered by Section 505(b)(2) DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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should be submitted within 60 days of publication of the Federal Register notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified w