By Cole Werble
It seemed like a good idea at the time. Fifteen months ago, the Food & Drug Administration, under intense pressure...
FDA's senior management is worried that it may have created a political Frankenstein when it called for an outside review of the agency's role in drug safety decisions by the Institute of Medicine. The agency asked for the study to take the heat out of Congressional efforts to split up safety and efficacy reviews. The committee has shown interest in the arguments to create new publicly-funded centers for post-market trials.
By Cole Werble
It seemed like a good idea at the time. Fifteen months ago, the Food & Drug Administration, under intense pressure...
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.