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

Senate's Medical Innovation Bill Takes Cures' Shape

This article was originally published in The Pink Sheet Daily

Executive Summary

HELP Committee chairman finally calls his package a companion to 21st Century Cures bill, but more work is necessary to bring it in line with the House legislation.

You may also be interested in...



US FDA Guidance Production May Be Slowed By New OMB Review Requirement

White House says all guidances, as well as proposed rules, must be submitted to OMB for a determination whether they are major or minor.

Former FDA Official Calls For 483 Reforms, Notes Caveats

Public scrutiny has made 483 results much more impactful than intended, says Howard Sklamberg, former FDA deputy commissioner for global regulatory operations and policy. He reminds stakeholders that information in them is preliminary.

Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates

OPEN ACT would provide additional six months of exclusivity when existing drugs are approved for rare diseases; congressional debate over the measure could get bogged down in drug pricing issues.

Related Content

Topics

UsernamePublicRestriction

Register

PS079384

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