FDA approves an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from two Phase 3 trials in the labeling that...
FDA regulatory consulting firm Greenleaf Health hires recently retired CDER Office on New Drugs (OND) director John Jenkins as principal for drugs and...
Skadden Arps attorneys say documents issued by FDA on off-label communications stress the agencys belief in its ability to regulate such communication...
A just-released FDA-483 details 13 observations from a 2015 inspection at CP Pharmaceuticals.
FDA warns Italys Facta Farmaceutici about CGMP violations in its production of finished pharmaceuticals.
FDA warns Germanys Biotronik about Quality System violations in its manufacturing of several medical devices.
FDA direct-to-consumer advertising researchers say that distracting visual elements can pull viewer attention away from mandatory risk information in ...
FDA clears two devices made by NICO Corp. that are used in a new approach to brain surgery.