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Dont Use Medtronic NIM EMG Endotracheal Tubes: FDA

[ Price : $8.95]

FDA cautions healthcare providers and facilities to heed a Medtronic urgent recall of all models and lots of its NIM EMG Contact a...

UniQure Seeking Accelerated Approval Path for Gene Therapy

[ Price : $8.95]

UniQure says it will meet soon with FDA to discuss potential expedited clinical development pathways and accelerated approval afte...

CGMP Violations at S. Koreas ReBom Co.

[ Price : $8.95]

FDA warns South Koreas ReBom Co. about CGMP violations in its manufacturing of OTC drugs.

Inspire Recalls Implantable Pulse Generator

[ Price : $8.95]

Inspire Medical Systems recalls its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can...

Draft Guide on Addressing Product Misinformation

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Federal Register notice: FDA makes available a revised draft guidance entitled Addressing Misinformation About Medical Devices and...

Draft Guide on Use-Related Risk Analyses

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Federal Register notice: FDA makes available a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs,...

Optikem CGMP Violations Cited

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FDA warns Denver, CO-based Optikem about CGMP violations in its production of finished drugs.

CBER Updates 2024 Guidance Agenda

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CBER publishes an updated 2024 guidance agenda with 20 listings.

Elevar Resubmitting Cancer Drug NDA

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Elevar Therapeutics says that after a meeting with FDA it is ready to resubmit its NDA for rivoceranib in combination with camreli...

Obsidian Gets Fast Track for OBX-115

[ Price : $8.95]

FDA grants Obsidian Therapeutics a fast track designation for OBX-115, a T cell immunotherapy in combination with a pharmacologica...