Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.
FDA clears a Baxter International 510(k) clearance of its new Novum IQ syringe infusion pump with Dose IQ Safety Software.
Amneal Pharmaceuticals files an NDA for IPX203, a novel formulation of carbidopa/levodopa extended-release capsules for treating Parkinsons disease.
Three patient advocacy groups sue HHS and the Centers for Medicare and Medicaid Services over their support for insurance companies and pharmacy benef...
Beam Therapeutics says it will complete studies requested by FDA as part of a clinical hold on a Beam-201 cancer treatment IND and submit its response...
FDA warns Missoula, MT-based Elite One Source Nutritional Services about dietary supplement CGMP and misbranding violations.
The Medical Device Information Consortium publishes information from a working group looking at the benefits of and approaches to using patient prefer...
FDA commissioner Robert Califf says the agency has launched a drug overdose prevention framework with four overarching priorities.
