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

Complex Generics May Be Part Of White House Drug Pricing Response

Executive Summary

Document that appears to be fueling upcoming executive order includes ideas for relaxing FDA standards for complex generic approval, which may be one way of creating pressure to lower prices.

You may also be interested in...



Complex Generic Approval Delays Getting Congressional Attention

US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.

US FDA Looks To Proactively Update Old Generic Drug Labels Under Pilot

Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.

US FDA Looks To Proactively Update Old Generic Drug Labels Under Pilot

Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID034708

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