美国FDA 指导原则 根据《平价医疗法案》6004条报告药品样本信息 英文原版.pdfVIP

Guidance for Industry Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Division of Dockets Management (HFA-305), Food and Drug Administration, 5630