Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Indian CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies For US FDA

This article was originally published in SRA

Executive Summary

In a rare move, the US Food and Drug Administration has sent letters to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) telling them that they will have to repeat bioequivalence and bioavailability studies conducted by the Indian contract research organization Semler Research Center Private Ltd. for their approved products and pending applications1.

Advertisement

Related Content

Top FDA Compliance Official Notes 'Revival' Of Data Integrity Fraud
Advertisement
UsernamePublicRestriction

Register

PS118629

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel