Generics Bulletin 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

New Supplement Timelines, Categories Proposed For BsUFA III

Executive Summary

The ideas could potentially address sponsor concerns about the effects of slow reviews.

You may also be interested in...



US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement

Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

BsUFA III Negotiations Nearly Done; Commitment Letter Being Written

Supplement approval timeline and regulatory science issues apparently have been resolved.

‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively

ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.

Related Content

Topics

UsernamePublicRestriction

Register

GB150887

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