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

CDER Policy Council Urged To Address Manufacturer/Payer Communications

Executive Summary

PhRMA and the Medical Information Working Group say the lack of clarity around FDAMA Sec. 114’s provisions governing dissemination of health care economic data to formulary committees warrants the medical policy council’s attention.

You may also be interested in...



FDA Promises More Off-label Guidances As Part Of First Amendment Harmonization

Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.

Senior CDER Management Panel Could Facilitate Novel Therapy Approval

CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel.

Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says

FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS055572

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