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QS Issues Found in Tianjin Bolang Science Tech. Inspection

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FDA warns Chinas Tianjin Bolang Science Technology Development Co. about Quality System violations in its production of three medi...

BlackBerry QNX Cybersecurity Vulnerabilities

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FDA says it is working with federal agencies, medical device manufacturers, and the private sector to resolve cybersecurity vulner...

Abbott PMA Approved for Amplatzer Amulet

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FDA approves an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who ar...

Comments Extended for Drug Scheduling Notice

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Federal Register notice: FDA is reopening the comment period for a 7/23 notice on international drug scheduling convention for fiv...

AstraZeneca Can Export Vaccine Made at Emergent Bio: FDA

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CBER says AstraZeneca can export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions troubled cont...

Pfizer/BioNTech Booster Data Submitted to FDA

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Pfizer and BioNTech submit Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine.

Studies Confirm Boston Scientifics Mesh Withdrawal

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Two Boston Scientific post-market surveillance studies confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scient...

Thermo Fisher Gets 2 EUAs for Covid Tests

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FDA grants Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath C...

Lillys Lyumjev OKd for Insulin Pump

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FDA approves Eli Lillys rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL for administration by continuous...

Former FDA Head Hahn Urges FDA Independence

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Former Trump administration FDA commissioner Stephen Hahn urges more independence for the agency to prevent political interference...