In interview with the Pink Sheet, Commissioner Gottlieb credits career staff, not his leadership, with many of the policy shifts.
The US FDA has made no shortage of policy announcements during Scott Gottlieb's first year as commissioner, with the agency rolling out new measures to promote competition, curb the opioid epidemic and incentivize new drug development.
The hefty policy pronouncements coming out the agency have often won praise from supporters and critics alike, creating an impression...
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.
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.
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