FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representati...
An advocacy group takes aim at FDA, arguing in a new report that the agencys drug review process has grown more costly and restrictive.
USC associate professor Genevieve Kanter says she is skeptical that the wholesale firing of HHS advisory committee experts to eliminate industry influ...
Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.
On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian methodology in drug an...
Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury or death.
Wave Life Sciences reports new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy WVE-007 produced str...
The National Association of Manufacturers calls on FDA to adhere to statutory and regulatory provisions governing expert panel meetings so stakeholder...
