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

US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars

Executive Summary

Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.

You may also be interested in...



BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency

New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.

BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency

New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.

‘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

Related Companies

UsernamePublicRestriction

Register

PS144003

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