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 Bill Would Prevent Safety Label Carve-Outs From Delaying Approvals

Executive Summary

Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.

You may also be interested in...



Senate Drug Pricing Legislation Clears Committee With Generic Exclusivity “Parking” Provision Unchanged

US Senate health committee advanced the Lower Health Care Costs Act with few pharma-related changes. Bill’s drug pricing provisions include the CREATES Act and a requirement that manufacturers report to HHS on price increases.

How Should Medicaid Pay For Cures? Sen. Grassley Likes Annuity Model

Finance Committee chairman wants a provision allowing Medicaid to make installment payments for high-cost curative treatments in drug pricing legislation. But Democrats worry such a model might encourage high prices.

Biologics Transition 'Dead Zone' Could Be Eliminated Under US Senate Bill

Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS125503

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