Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Generic Labeling Problems Targeted In US FDA Budget Request

Executive Summary

Agency seeks legislative authority to update outdated generic drug labels when the reference product has been withdrawn.

You may also be interested in...



FDA Review Modernization Fully Funded

After receiving $25.1m in FY 2019, Congress gave another $1.9m in FY 2020, which appropriators said combined reaches the $27m requested for the FY 2020 budget.

Generics Modernization Effort At US FDA Receives Full Funding Over Two Years

After receiving $25.1m in FY 2019, Congress gave another $1.9m in FY 2020, which appropriators said combined reaches the $27m requested for the FY 2020 budget.

Senate Bill Would Prevent Safety Label Carve-Outs From Delaying Approvals

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

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS124995

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