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FDA in 3 More Collaborative Communities

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FDA says it is participating in three new medical device collaborative communities.

House Committee Threatens FDA Subpoena

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House Energy and Commerce Committee Republicans threaten to subpoena FDA if it continues to not produce foreign drug inspection in...

Abbott PMA for GLP Systems Track

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FDA approves an Abbott PMA for its automated GLP systems Track, which is intended to support high-volume laboratory needs and maxi...

FDA Approves Medtronics Pulsed Ablation

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Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations...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