Pink Sheet is part 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

Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers

Executive Summary

New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.

You may also be interested in...



How Do You Know If A REMS Is Effective? Look At Postmarket Data, Surveys, Patient Access

US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.

Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act

Legislation that would prevent REMS from blocking generics appears to be gaining momentum.

Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act

Legislation that would prevent REMS from blocking generics appears to be gaining momentum.

Related Content

Topics

UsernamePublicRestriction

Register

LL016789

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