Generics Bulletin 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

Label Expansion: Could Clinical Experience Data Find Supplement Work-Around?

Executive Summary

Friends of Cancer Research seeks way of allowing high-quality efficacy data into label when supplemental NDA is not feasible.

You may also be interested in...



First Draft FDA User Fee Bill Is Squeaky Clean

House and Senate release discussion draft of user fee reauthorization legislation that does not include any additional policy or practice changes for US FDA, though they may arrive later.

A Hiring Freeze By A Different Name: OMB Wants Agency 'Workforce Reduction' Plans

Latest Office of Management and Budget directive lifts the pause on federal hiring, but requires US FDA and others to develop long-term plans to cut staff.

Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals

US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB002026

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