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


US FDA still getting to grips with REMS

This article was originally published in SRA

Executive Summary

The US pharmaceutical industry is concerned that the Food and Drug Administration is failing to meet its performance goals under the prescription drug user fee programme (PDUFA IV) because the agency is being slowed down by the implementation of the FDA Amendments Act, particularly with respect to risk evaluation and mitigation strategies1. At the Drug Information Association’s 45th annual meeting held in San Diego, US, on 21-25 June, Sandra Kweder, deputy director of the Office of New Drugs in the agency’s drugs centre, admitted that PDUFA deadlines had been affected in the past year as implementation had been a challenge.




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