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Early Alert on CooperSurgical Neonatal CPAP Ventilator

[ Price : $8.95]

FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal co...

Roche/Lilly Alzheimers Test Cleared

[ Price : $8.95]

FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identi...

HHS Seeks Input on Categories of Federal Vaccine Recommendations

[ Price : $8.95]

HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patie...

CBER Updates Process for Formal Disputes With Sponsors

[ Price : $8.95]

CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, estab...

Scholar Rock Removes Catalent Facility from BLA to Advance Apitegromab

[ Price : $8.95]

Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrop...

Lawmakers Urge FDA to Up Scrutiny of Clinical Data From China

[ Price : $8.95]

House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on cl...

FDA Issues New Guidance on Therapeutic Equivalence Evaluations

[ Price : $8.95]

FDA issues a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns thera...

Early Alert on : GE HealthCare Portrait Core Monitor Software

[ Price : $8.95]

CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected customers of updated use instru...

Boston Scientific Recalls ENROUTE Percutaneous Catheter Kit

[ Price : $8.95]

Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during...

4 Observations in Suretec Inspection

[ Price : $8.95]

FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.