Plan B Decision May Offer FDA Best Political Protection Available
Assuming that sexually charged products such as Teva’s emergency contraceptive remain subject to political decision-making, the explicit heavy hand of the HHS secretary in the OTC switch ruling may be the best approach for FDA and the Rx industry, especially considering the alternatives.
More from Agency Leadership
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.
More from Pink Sheet
- • By
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.
- • By
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.’
- • By
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.





