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Biden's COVID-19 Advisory Board Bodes Well For Science-Driven FDA

 
• By Sarah Karlin-Smith

Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.

11/07/2020, USA: Democratic presidential nominee Joe Biden speaks as vice presidential nominee Sen. Kamala Harris listens at The Queen theater, in Wilmington.
President-elect Biden announced his COVID-19 advisory board 9 November • Source: Shutterstock

The composition of US President-elect Joe Biden’s COVID-19 advisory board announced 9 November is a positive sign that the Food and Drug Administration will be free from the political tinkering that often colored the pandemic response of President Donald Trump's administration, potentially beginning a reversal in recent trends of decreased public trust in the agency and future coronavirus vaccines, experts said.

Two prominent former agency leaders, David Kessler, who served as FDA commissioner under Republican President George HW Bush and Democratic President Bill Clinton, and former FDA chief scientist Luciana Borio

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US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

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Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.