The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.
US Food and Drug Administration Commissioner nominee Robert Califf agreed to take fast and “strong action” to hold pharmaceutical companies accountable for producing the scientific evidence required of accelerated approval drugs if confirmed for a second chance at leading the agency, a 4 February letter from Senate Finance Committee Chair Ron Wyden says.
Califf made the pledge to take action within 30 days of assuming office during a recent meeting with the Democratic...
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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