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FDA Approves Medtronics Pulsed Ablation

[ Price : $8.95]

FDA approves a Medtronic PMA for the PulseSelect Pulsed Field Ablation System for treating both paroxysmal and persistent atrial f...

Nagy Debarred for 15 Years

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Federal Register notice: FDA issues an order debarring Adam Michael Nagy for a period of 15 years from importing any drug into the...

FDA Doing Little on Social Media Drug Claims: Report

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A Bloomberg Law article says FDA is doing little to address potentially violative social media drug ads.

Pharmasol Permanent Injunction Approved

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The Massachusetts federal court approves a consent decree of permanent injunction against Pharmasol and its president for continui...

Clinical Hold on 3 CARsgen CAR T-cell Therapies

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FDA places a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions ra...

Stakeholder Technical Issues with Ophthalmic Guide

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Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations...

FDA Approves Neuroblastoma Drug

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FDA approves a U.S. WorldMeds NDA for eflornithine for reducing the risk of relapse in certain adult and pediatric patients with h...

Update GAO Device Recall Oversight Report: Senators

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Sens. Durbin and Blumenthal ask the Government Accountability Office to update its 2011 report on FDA oversight of medical device ...

Novid Distributing Unapproved, Misbranded Drug: FDA

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FDA warns Northridge, CA-based Novid Group that it is illegally distributing an unapproved and misbranded over-the-counter antihis...

Vertex Moving Neuropathy Pain Drug to Phase 3

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Vertex Pharmaceuticals says it will advance selective NaV1.8 inhibitor VX-548 into pivotal Phase 3 studies based on positive resul...