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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...

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

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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

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

4 Observations in Suretec Inspection

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

No Quality Unit Seen in Safrel Pharmaceuticals Inspection

[ Price : $8.95]

FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.

FDA Issues Complete Response Letter for Xspray Pharmas Dasynoc

[ Price : $8.95]

FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.

Ultragenyx Gene Therapy OKd for Glycogen Storage Disease

[ Price : $8.95]

FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and child...