FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of absolute neutrophil co...
FDA releases the form FDA-483 issued following an inspection at the AstraZeneca Frederick, MD, drug manufacturing facility.
Emalex Biosciences says it will meet with FDA to discuss submitting an NDA for its ecopipam to treat Tourette syndrome following successful results fr...
FDA clears Tandem Diabetes Cares next-generation automated insulin delivery algorithm, Control-IQ+ technology, for use in people with Type 2 diabetes....
Ascent Consumer Products recalls one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test result of microbial c...
Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state claims against an over...
FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, South Korea.
Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.
