Consultant examines why FDA seems to be accomplishing so much under FDA Commissioner Gottlieb’s leadership and how this could inform future leadership selections.
“How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly. With amazing frequency, the questioner follows up with a twinkle in the eye and a statement that is similar to a rock star groupie suggesting: “Isn’t he dreamy?”
So, let me tell you, most FDA watchers who long to hear from the agency early and often, and who benchmark it by the rapid-fire announcements and new initiatives, think...
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.
