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Workshop on Transbronchoscopic Thermal Ablation Devices

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FDA announces a 4/5-6 virtual public workshop entitled Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) D...

FDA Accepts Lilly Ad Explanation

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The CDER Office of Prescription Drug Promotion accepts Lillys explanation of issues raised about Emgality TV ads and closes an unt...

Info Collection on Influenza Test Reagents

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Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance on Reagents for Detection of ...

Info Collection on Export Notifications

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Federal Register notice: FDA seeks comments on an information collection extension entitled Exports Notification and Recordkeeping...

FDA Rejects Merck NDA for Chronic Cough

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FDA issues Merck a complete response letter on its NDA for gefapixant, an orally administered selective P2X3 receptor antagonist f...

FDA Hits Viking Therapeutics with Clinical Hold

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FDA places a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrop...

Medtronic Neurostimulators OKd for Diabetic Neuropathy

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FDA approves a Medtronic PMA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for treating ch...

Ex-Clinical Study Manager Sentenced to 30 Months

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A Florida federal court sentences former clinical study coordinator Duniel Tejeda to 30 months in prison for his participation in ...

FDA Clears Biotricity Cardiac Monitor

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FDA clears a Biotricity 510(k) for its Biotres Cardiac Monitoring Device, a three-lead holter device for electrocardiogram and arr...

Cook Gets Breakthrough on Drug-eluting Stent

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FDA grants Cook Medical a breakthrough device designation for its new drug-eluting stent for below the knee use.