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要 約
FDA Guidance Document (旧:Guides #57)
FDA Guidance #57
論争の正式解決:医薬品のCGMP上の科学的、技術的問題点
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues related to Pharmaceutical CGMP

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Center for Biological Evaluation and Research
Center for Veterinary Medicine
Office of Regulatory Affairs
Pharmaceutical CGMPs
January 2006

Guidance for Industry
Formal Dispute Resolution: Scientific and
Technical Issues related to Pharmaceutical CGMP
論争の正式解決:医薬品のCGMP上の科学的、技術的問題点

目次[Table of Contents]
I.緒論[Introduction]
II.本ガイダンスの適用範囲[Scope of the Guidance]
III.論争の解決プロセス[Dispute Resolution Process]
 A.ORA、およびセンター・レベルでの第1段階の論争解決[Tier-One Dispute Resolution at Office of Regulatory Affairs and Center Levels]
 B.科学的、技術的問題のDRパネルによる第2段階の論争解決[Tier-Two Dispute Resolution with the DR Panel on Scientific and Technical Issues]
 C.論争解決の正式要請はどのように行うか[How to request Formal Dispute Resolution]
 D.製造業者が提出するサポート情報[Supporting Information to be provided by Manufacturers]
 E.論争解決の要請に対するFDAの回答[FDA Response to Requests for Dispute Resolution]
IV.正式論争解決に対す問題の適切性[Suitability of Issues for Formal Dispute Resolution]
 A.CGMP規則の適格な要素の遵守欠如[Failure to comply with a Precise Element of CGMP Regulations]
 B.承認された申請で要求された的確な要求事項の遵守欠如[Failure to comply with a Precise Requirement established in an Approved Application]
 C.的確な要求事項の遵守欠如の法的重要性[The Regulatory Significance of Failing to comply with a Precise Requirement]
 D.査察中以外で発生した問題点[Issues not raised during the Inspection]
Ⅴ.論争解決の決定の通知[Communication of Dispute Resolution Decisions]
Ⅵ.1995年書類削減法[Paperwork Reduction Act of 1995



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