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

Expanded Access Amendment Could Blunt 'Right To Try' Legislation In US

Executive Summary

Senate's user fee legislation would now require FDA and NIH to hold a public meeting about how to broaden clinical trial enrollment; amendment offers a more subtle approach to increase access to experimental treatments than does 'right-to-try legislation.

You may also be interested in...



User Fee Bill Or Drug Pricing Bill? House Members Makes Both Cases

House passes bill reauthorizing FDA user fee programs via voice vote and makes many other policy changes, but in the process touts the bill's potential to push drug prices lower.

User Fee Reauthorization: 'Pre-Conferenced' Bill Aims For Quick Passage

'Clean' bill includes expanded access language from Senate, generic review revisions from House as legislators hope for enactment this month.

Regenerative Medicines Provisions Of Cures Act A Top Priority For CBER

CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.

Related Content

Topics

UsernamePublicRestriction

Register

LL111109

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