US FDA commissioner nominee suggests breakthrough concepts should be more widely adopted within the review divisions and that staff should find and distribute best practices.
Scott Gottlieb expects ideas for creating more consistency within FDA's review divisions, particularly in embracing the breakthrough therapies program, would come from his own staff.
During an April 5 Senate Health, Education, Labor and Pensions Committee hearing on his confirmation as FDA Commissioner, Gottlieb promoted...
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
