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FDA releases the form FDA-483 with four observations from an inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility.[ Price : $8.95]
FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal ...[ Price : $8.95]
AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or ...[ Price : $8.95]
FDA approves safety labeling changes for fluorouracil injection products when used in patients with dihydropyrimidine dehydrogenas...[ Price : $8.95]
Vyaire Medical recalls certain AirLife Manual Resuscitators due to a manufacturing defect.[ Price : $8.95]
A House Energy and Commerce Health Subcommittee hearing discusses the need to legislatively reform FDAs oversight of laboratory-de...[ Price : $8.95]
Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) d...[ Price : $8.95]
Abiomed recalls its Impella Left Sided Blood Pumps because the pump catheter may slice the hearts left ventricle wall during proce...