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

CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On

Executive Summary

Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.

You may also be interested in...



As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing

US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.

Lower FY22 PDUFA Fees Realized In US FDA Recalculation For Hiring, Attrition Concerns

Agency reissued user fee notice, saying fewer dollars were needed for adding staff. After concerns about process misunderstandings, agency withdrew earlier version of fee notice.

US FDA Lowers FY '22 PDUFA Fees Due to Hiring, Attrition Concerns

The agency reissued the user fee notice, saying fewer dollars were needed for new staff.

Related Content

Topics

UsernamePublicRestriction

Register

PS142445

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