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

FDA Role In Risk Management Should Be “Broad Societal Decision,” Hamburg Says

This article was originally published in The Pink Sheet Daily

Executive Summary

A survey of well-informed voters conducted by the health policy institute NEHI found respondents were in favor of marketing products that might pose a risk, as long as FDA disclosed the potential dangers. Commissioner Hamburg says she is “pleased and frankly a little surprised” by the depth of appreciation for the agency’s work shown by the survey.

You may also be interested in...



Senate Accelerated Approval Draft Needs “FAST” Changes, House Members Say

Reps. Stearns and Towns want the Senate draft to more closely align with their FAST Act by adding language that would allow greater flexibility for development of rare disease treatments.

Risk-Sharing Drug Rebate Contracts: Do They Live Up To The Hype?

Manufacturers and payers will continue to work on innovative pricing arrangements, roundtable panelists said, but they are likely to be less complex and resource intensive than many of the risk-sharing contracts announced to date, particularly in Europe.

FDA’s Regulatory Flexibility On Display In Review Of Innovative Agents

Regulatory flexibility is the backbone of FDA’s success in efficiently reviewing new drugs and biologics, especially on the frontiers of unmet medical needs, Pharmaceutical Approvals Monthly’s 2011 series of drug review profiles shows.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS074106

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