By Ramsey Baghdadi
"I am so tired of people saying that FDA is a train wreck waiting to happen," Food & Drug Administration...
The Institute of Medicine's drug safety committee came down hard on FDA's efforts to make sure drugs they approve are safe and effective. But FDA dodged a bullet based on what isn't in the report.
By Ramsey Baghdadi
"I am so tired of people saying that FDA is a train wreck waiting to happen," Food & Drug Administration...
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.