Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry as a diagnosis of a...
A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.
Two former FDAers petition the agency to appoint an advisory committee to consider whether anticholinergic drugs are associated with an increased risk...
FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing fac...
FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at its South El Monte, ...
A Ropes & Gray legal update examines FDA initiatives to shorten drug development timelines and reduce regulatory burdens for sponsors.
Four stakeholders express varying opinions on the future direction and existence of the FDA national priority drug voucher program.
FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unapproved ophthalmic devices.
