Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

REMS Abuse Website: All Sizzle, No Steak?

Executive Summary

AAM President Davis contends he hasn't seen any evidence showing that reference listed drug access inquiries webpage has changed innovator behavior.

You may also be interested in...



Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

FDA Talks Tough On Complete Response Extensions

The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS123815

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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