FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews
By EsqSocial Corporation 03/04/25
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications (NDAs) that relied on bioequivalence studies conducted by Raptim Research Pvt. Ltd, a contract research organization based in Navi Mumbai, India....
By: ArentFox Schiff