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