FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle.
On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian methodology in drug and biological product clinical trials.
FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle.
On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian methodology in drug and biological product clinical trials.
FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representatives for an alternative to FDA’s proposed America First fee incentive effort.
The FY 2025 report on GDUFA-funded science and research tells how the research supported the development of product-specific guidances and the approval of generic liraglutide products.
