FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.
FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle.
The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.
Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.
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...
On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian methodology in drug an...
FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representati...
