US FDA Commissioner Scott Gottlieb sat down with the Pink Sheet and Medtech Insight reporters for an exclusive chat about his ongoing regulatory work and plans for the future.
Promoting competition among new drugs does not necessarily mean encouraging development of so-called "me-too" products and the limited band-width of FDA's document redaction effort may mean the release of complete response letters is not prioritized, FDA Commissioner Scott Gottlieb told the Pink Sheet in a recent interview.
Gottlieb spoke Nov. 3 at the National Press Club in Washington, D.C. (Also see "Gottlieb Promotes 'Team' Work For...
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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