Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts