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

Preapproval Safe Harbor Should Extend 18 Months, Payers And Sponsors Say

Executive Summary

Manufacturers should be allowed to talk to payer representatives involved in financial forecasting about a new drug well before FDA approval, group led by Academy of Managed Care Pharmacy says.

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.

Alzheimer’s Drugs and Medicare: A Case For Pre-Approval Discussions

Medicare's Part D plan bidding schedule and uncertainty over the Alzheimer’s drug pipeline is putting plan sponsors in a difficult situation as they contemplate their 2018 bids.

FDA's Off-Label Communication Changes Should Start With Payers – PhRMA

PhRMA Senior Counsel Jeffrey Francer offers three-step reform approach to loosening FDA’s restrictions, beginning with the 'low-hanging fruit' of talking with payers.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119236

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