The US Food and Drug Administration has announced a new case of data falsification, just a few days before contract research organizations must comply with mandatory registration rules in India.
Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies
The FDA Analyzed BE Studies Conducted Between 2019 And 2023
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
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