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Former Official Faults U.S. FDA For Approving Ranbaxy Drugs

This article was originally published in PharmAsia News

Executive Summary

A former U.S. FDA official says the agency should have frozen 18 approvals for generic drugs submitted by Ranbaxy Laboratories during a time it was investigating the Indian firm for false data. Mary Pendergast, a former deputy commissioner and now consultant to pharmaceutical and medical-device makers, said in an interview the agency should not have been approving any of the 18 products knowing it could not be "confident of the accuracy and reliability of the information in the applications." A congressional committee is probing the matter along with the Justice Department, which revealed its doubts about the information in court papers. (Click here for more
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