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

Payers Want Access To US FDA's Pre-Submission Meetings

Executive Summary

As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.

You may also be interested in...



'Safe Harbor' For Preapproval Information Exchange To Get Legislative Push

US Academy of Managed Care Pharmacy is developing language to protect exchange of clinical and economic information on pipeline products between manufacturers and healthcare decision-makers; safe harbor could find a home in legislation reauthorizing FDA user fee programs.

Pharma CEOs Tackle A Tough Question: “Why Don’t People Like You?”

Pfizer CEO Ian Read, Regeneron CEO Leonard Schleifer, Gilead CEO John Milligan and Lilly’s incoming CEO David Ricks discussed pharma’s reputation problem during the Forbes Healthcare Summit.

Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119505

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