FDA warns SC Johnson (formerly Deb USA) about CGMP and other violations in its production of finished pharmaceuticals.
FDA accepts for priority review a Merck BLA for its investigational Ebola vaccine.
FDA clears a Canon 510(k) for its Xephilio OCT-A1 Optical Coherence Tomography device for in-vivo imaging and measurement of the retina, retinal nerve...
FDA, Australia, and Canada collaborate for the first Project Orbis simultaneous drug approval for Lenvima and Keytruda to treat a particular endometri...
The Coalition for Healthcare Communication reports that five research studies conducted by CDERs Office of Prescription Drug Promotion are awaiting pe...
Five stakeholders recommend changes to an FDA draft guidance on population pharmacokinetics.
FDA releases its latest batch of Warning Letters that includes Deb USA and 21st Century Scientific.
Former FDA commissioner Scott Gottlieb joins Aetions board of directors.