Organon asks FDA to put restrictions on ANDA applications citing Organons Nexplanon as the reference-listed drug.
FDA releases the form FDA-483 with four observations from an inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility.
FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal or ocular tests as p...
AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or calcium phosphate co...
FDA approves safety labeling changes for fluorouracil injection products when used in patients with dihydropyrimidine dehydrogenase deficiency.
Vyaire Medical recalls certain AirLife Manual Resuscitators due to a manufacturing defect.
A House Energy and Commerce Health Subcommittee hearing discusses the need to legislatively reform FDAs oversight of laboratory-developed tests instea...
Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) did not meet its prim...