美国FDA 指导原则 场外专著订购要求格式和内容 英文原版.pdfVIP

Over-the-Counter Monograph Order Requests (OMORs): Format and Content Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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