Bipartisan legislation is introduced to ensure that generic drug developers have access to needed reference-listed product samples.
FDA warns Mylan about CGMP and data integrity violations at its finished pharmaceuticals plant in Maharashtra, India.
FDA clears a Verax 510(k) to expand the indications for the Verax Platelet PGD Test to include single units of leukoreduced or non-leukoreduced whole ...
Isomeric Pharmacy Solutions recalls all lots of sterile products compounded and packaged that remain within expiry to the hospital/user level due to F...
Philips Healthcare recalls its Mobile Diagnostic X-Ray System with Digital Panel due to a software design issue.
FDA tells Repros Therapeutics that a partial clinical hold will continue against Proellex (telapristone acetate) and its use in treating uterine fibro...
A Morning Consult op-ed by ex-FDAers urges President Trump to back four steps on promoting generic drugs, improving drug quality, easing regulatory bu...
Medtronic recalls all unused units of the StrataMR adjustable valves and shunts due to an increase in product complaints, a rate estimated at 2.75% pe...