Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.
FDA refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.
A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit versions of popular...
The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.
Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.
FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.
FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its findings on two studies ...
