Federal Register notice: FDA corrects a 10/22/2021 notice that announced the withdrawal of 216 ANDAs.
CDRH releases its Health of Women Program Strategic Plan that intends to boost related regulatory science, and identify and address current and emergi...
Medtronic says its DTM SCS endurance therapy showed meaningful pain relief results in a clinical trial.
FDA warns Schaumburg, IL-based Sunstar Americas about drug CGMP and medical device QS violations at its manufacturing facility.
FDA releases three case study summaries from the complex innovative trial design pilot program.
FDA issues the latest FDA-483 from an inspection at the troubled Catalent fill and finish contract manufacturing facility in Brussels, Belgium.
FDA warns South Koreas Cosmo Bio about CGMP violations in its production of a misbranded and unapproved over-the-counter acne drug.
FDA issues Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and...