Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the...
FDA posts a guidance on new enforcement deferments affecting enhanced drug distribution security requirements.
Inmar Supply Chain Solutions recalls FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, dietary supplements, f...
CDER asks for comments on its proposal to withdraw Oncopeptides accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide).
CDRH announces the qualification of a new tool through the agencys voluntary Medical Device Development Tools program: Accelerated Testing to Prove Lo...
FDA clears a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the companys VersiHD chronic home hemodialys...
FDA grants Redx an orphan drug designation for zelasudil (RXC007) for treating idiopathic pulmonary fibrosis.
Medtronic issues an Urgent Medical Device Communication about its HeartWare Ventricular Assist Device (HVAD) systems and a newly identified subgroup o...
