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.
Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically signific...
FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.
Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2019 government shutd...
Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.
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.