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

Some US FDA Advisory Committee Meetings Likely To Remain Virtual Post-Pandemic

Executive Summary

Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.

You may also be interested in...



Adcomm Member Survey Shows Continued Support For Virtual Meetings After Pandemic

Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.

Pondering The Future Of In-Person Meetings At The US FDA

Stakeholders believe virtual meetings should remain an option going forward, but that in-person sessions should still be convened in many cases.

What Did US FDA Do Wrong In Its Review Of Aducanumab? AdCom Members Have A List

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144947

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