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

Waivers For Shared REMS Will Depend On Impact To Generics, Docs, Patients

Executive Summary

US FDA will take multiple factors into account when deciding whether single shared-system REMS requirement is necessary.

You may also be interested in...



Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition

In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.

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US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.

Will CBO Score CREATE Momentum For Generic Bill's Passage?

Strong savings estimate – and brand pharma's need to have pay-fors for its own legislative priorities – could finally get bill allowing generic companies to sue brand sponsors for access to samples.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132115

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