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

US FDA's Hahn Promotes Provider Role In Boosting Public Confidence In COVID-19 Products

Executive Summary

Agency commissioner appeals to AMA audience to communicate message that FDA review decisions are based on good science.

You may also be interested in...



US FDA COVID-19 Adcom: What Additional Members Are Needed?

Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application. 

US FDA Clarifies: Coronavirus Vaccine Will Need Adcom Before Approval Decision

In a JAMA article, senior FDA leaders state that the outside advisers will be needed to ensure transparency given the potentially widespread use of the vaccine.

Preapproval Promotion? US FDA Commissioner Touts ‘Lifesaving’ Investigational Plasma For COVID-19

Hahn’s communications, which go far beyond the claims a sponsor could make of an investigational product, are raising new concerns about the agency’s ability to serve as a science-based regulator during the coronavirus pandemic. HHS Secretary Alex Azar and NIAID Director Anthony Fauci have also touted the lifesaving nature of plasma donations for COVID-19, even though the treatment is still unproven.

Related Content

Topics

UsernamePublicRestriction

Register

ID001014

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