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A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medic...[ Price : $8.95]
FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal z...[ Price : $8.95]
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an ...[ Price : $8.95]
FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotex...[ Price : $8.95]
CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepat...[ Price : $8.95]
An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients wi...[ Price : $8.95]
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.[ Price : $8.95]
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing f...