Pink Sheet Podcast: US COVID-19 Booster Plan, Restated PDUFA Fees, More FDA Adcomm Power?
Pink Sheet reporter explains the increased pressure on the FDA now that a coronavirus vaccine booster plan is in place, the surprising results of a survey of agency advisory committee members, and the recalculation of FY 2022 PDUFA fees.
You may also be interested in...
Senators ask US FDA to change statements in COVID-19 monoclonal antibody fact sheets that factors like race or ethnicity may place a patient high-risk of serious illness, saying they promote racist decisions.
Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.
US FDA adds a warning about immune thrombocytopenia, joining the risk of Thrombosis with Thrombocytopenia Syndrome.