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

FDA Pressed To Clarify Permissible Formulary, Clinical Guideline Communications

This article was originally published in The Pink Sheet Daily

Executive Summary

Citizen petition from seven firms asks agency to issue regulations related to four areas of off-label communications.

You may also be interested in...



FDA Guidance On Health Care Economic Data Is Coming In 2015

Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.

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.

CDER Policy Council Urged To Address Manufacturer/Payer Communications

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS072591

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