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Alert on Boston Scientific Defibrillation Leads

[ Price : $8.95]

FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads tha...

FDA Early Alert on Watchman Devices

[ Price : $8.95]

FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use i...

Quarantine Some Medline ReNewal Catheters

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An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due t...

FDA Accelerated Approval for Jazz Modeyso

[ Price : $8.95]

FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.

FDA Publishes Data Standards Program Update

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FDA publishes the FY 2025 Quarter 2 update to the CBER/CDER Data Standards Program Action Plan.

Clarametyx Gets Fast Track for Pulmonary Infection Drug

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FDA grants Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic c...

Mectronic Medicale Multiple Violations

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FDA warns Italys Mectronic Medicale about Quality System, Medical Device Reporting, and other violations in its illegal manufactur...

Two-Day Workshop on Oncology Patient Registries

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FDAs Oncology Center of Excellence announces a two-day virtual public workshop to advance the development of patient registries in...

CGMP Violations at Oasis Medical

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FDA warns Glendora, CA-based Oasis Medical about CGMP violations in its production of finished drugs.

Laura Loomer Targets Makary Over Prasad Exit

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Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departu...