A new research article by FDA and European regulators finds their good clinical practice inspection processes to be equivalent, which supports an ongo...
FDA classifies as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronization therapy defibril...
A new FDA report on Covid-19 activities notes that the agency is initiating a new inspection planning system that will be more efficient, transparent,...
A just-completed FDA inspection of Sun Pharmaceutical Industries Punjab, India manufacturing facility leads to a six-item Form FDA-483 that cites GMP ...
FDA sends India-based Cipla Ltd. a two-item Form FDA-483 after a recent inspection at its Madhya Pradesh, India manufacturing plant.
FDA revises a Pfizers emergency use authorization for Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-moderate Covid-19 to req...
FDA clears a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determining visual acuity.
Federal Register notice: FDA sends to OMB an information collection extension entitled Center for Devices and Radiological Health Appeals Processes.
