Top Senate committee Democrat Patty Murray tweeted concerns about Gottlieb's positions on 'gold standard' of FDA approval; Public Citizen's Michael Carome ultimately thinks Gottlieb will be approved.
Tweets from top Senate HELP Committee Democrat Patty Murray, D-Wash., suggest that Scott Gottlieb will face a line of questions focused on approval standards during his eventual Senate confirmation hearing to be FDA commissioner.
"There are concerns w/ Dr. Gottlieb’s record & about how his views would impact our ability to maintain the 'gold...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
