John Evans

John Evans

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more

5/12/2025  /  Clinical Trials , Data Integrity , Enforcement Actions , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements
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