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

User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data

Executive Summary

Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.

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.

Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says

New US FDA commissioners have a lot of housekeeping to do before they can get to the fun stuff, according to former associate commissioner Wayne Pines.

Generic Priority Review Expanded In Senate User Fee Bill

Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.

Related Content

Topics

UsernamePublicRestriction

Register

MT142464

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