Acting commissioner Janet Woodcock will remain at the agency and become principal deputy commissioner when Califf arrives.
Robert Califf, who squeaked through the US Senate to become the first person confirmed twice as Food and Drug Administration commissioner, will return with urgent items already on his agenda, including some pushed to the top to smooth his path to the job.
Califf received only 50 votes in favor of confirmation on 15 February, which was the lowest total a nominee to head the FDA has received. Scott Gottlieb previously had received...
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
