美国FDA 指导原则 根据BLA、NDA或PMA批准的组合产品的批准后修改的提交 英文原版.pdfVIP

Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 written comments to the Division of Dockets Management (HFA-305), Food and Drug Admini