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

FDA Cites Celgene For Tardy Adverse Event Reporting On Thalomid

This article was originally published in The Pink Sheet Daily

Executive Summary

Celgene has hired a new contractor to process adverse event reports for thalidomide, although the agency says it will have to “assess the adequacy of the correction during a future inspection.” An FDA letter cites 82 instances of delayed reports.
Advertisement

Related Content

Celgene Thalomid Multiple Myeloma sNDA Is "Approvable"
Celgene Thalomid Multiple Myeloma sNDA Is "Approvable"

Topics

Advertisement
UsernamePublicRestriction

Register

PS060378

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