A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting continue to dominate the Center’s enforcement findings.
FDA approves Juno Therapeutics’ CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma.
A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting continue to dominate the Center’s enforcement findings.
FDA approves Juno Therapeutics’ CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma.
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committee to recommend stopping the trial early for efficacy.
FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotex’s sterile drug facility in Richmond Hill, Ontario.
