COVID-19, The US FDA – And Twitter
Executive Summary
It is far from the most important aspect of the government response to the global pandemic, but the COVID-19 outbreak includes some memorable milestones in the embrace of social media as a communication tool by the US FDA – and some individual FDAers.
You may also be interested in...
COVID-19 Staff Shakeup: Woodcock Moves to Commissioner's Office As Marks Drops Out Of 'Warp'
CBER Director Marks will no longer have to recuse himself from COVID-19 product reviews, a move seen as resoundingly positive by former senior FDA leaders. CDER Director Woodcock will now be free to focus solely on COVID-19 and bring her unique depth of agency experience to the Trump Administration's effort to speed development of vaccines, therapeutics and diagnostics for coronavirus.
Woodcock Said To Have Guided Hydroxychloroquine EUA In ‘Brokered Compromise’ To Limit Use
In whistleblower complaint, Rick Bright claims FDA Commissioner Hahn advocated for distributing hydroxychloroquine to pharmacies across the US, a departure from the approved emergency use authorization. Bright's complaint paints CDER Director Woodcock in a favorable light, saying she helped avoid an expanded access IND protocol for the potential coronavirus treatment.
CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’
In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.