FDA CSA Draft Guidance with Bilingual Translation
[Preliminary] FDA’s Draft CSA Guidance Issued on September 13, 2022.
【translation into Japanese】FDA Part 820 QMSR(Quality Management System Regulation)revised plan
Are FDA inspectors good?
Department of Health and Human Services (HHS) criticizes the status of FDA’s overseas inspections
FDA Plans to Issue Part 11 Q&A Guidance
FDA U.S. inspections resumed
リモート査察について