FDA draft guidance Archives

HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

Bloomberg Gov, October 23, 2020. Scientists and advocates challenge coronavirus vaccine testing standards at FDA advisory meeting.

FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel

WSJ, October 23, 2020. FDA promises strong safety testing for coronavirus vaccines even as current standards criticized at advisory meeting.

FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting

Bloomberg Business, October 23, 2020. We, with other, scientists and advocates criticize weak Covid-19 vaccine standards at FDA Advisory Panel Meeting.

FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine

NPR, October 22, 2020. Dr. Diana Zuckerman spoke about making sure vaccines aren’t rushed through too quickly to be safe at the FDA advisory meeting on Covid-19 vaccine approval.

NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population

August 31, 2020: We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.