An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits....

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Bibliographic Details
Main Authors: Bose, D. (Author), Gogtay, N.J (Author), Saha, S. (Author), Saxena, U. (Author), Thatte, U.M (Author)
Format: Article
Language:English
Published: NLM (Medline) 2022
Online Access:View Fulltext in Publisher