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
UsernamePublicRestriction

Back To Normal? US FDA Schedules In-Person Meeting But Pauses Non-COVID Guidance Development

Executive Summary

As the agency and country plot the steps to reopening, a full resumption of activities still seems a long way off.

You may also be interested in...



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

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

Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19

Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.

US FDA’s Gene Therapy Work Feeling The Effects Of Pandemic Response

CBER’s heavy COVID-19 workload is pushing other things to the side, causing delays in sponsor meetings and issuance of new guidance documents, and a slowdown in efforts to streamline development of individualized therapeutics, biologics center leaders tell BIO Digital 2020.

Related Content

Topics

UsernamePublicRestriction

Register

MT142639

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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