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

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...



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

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.

ViroPharma’s Failed Exclusivity Bid For Vancocin Could Spur Congress To Act

FDA’s decision that vancomycin oral capsules do not qualify for Hatch-Waxman marketing protection under a 2008 law could become the focus of a legislative “fix” in pending user fee bills if lawmakers disagree with the agency’s conclusion that only approval of a “significant new use” for older antibiotics warrants exclusivity.

Accelerated Approval Bill In Senate Tracks House Draft, But With More Of A Nod To FDA

The Senate measure adds a provision on breakthrough therapies and specifies that accelerated approval provisions do not alter substantial evidence standard used to approve drugs.

Related Content

Topics

UsernamePublicRestriction

Register

PS074005

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