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Human Drugs

House Committee Threatens FDA Subpoena

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

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Medical Devices

Abbott PMA for GLP Systems Track

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

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Medical Devices

FDA Approves Medtronics Pulsed Ablation

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

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Federal Register

Nagy Debarred for 15 Years

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

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Marketing

FDA Doing Little on Social Media Drug Claims: Report

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

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Human Drugs

Pharmasol Permanent Injunction Approved

The Massachusetts federal court approves a consent decree of permanent injunction against Pharmasol and its president for continuing to distribute adu...

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Human Drugs

Clinical Hold on 3 CARsgen CAR T-cell Therapies

FDA places a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions raised in a recent ins...

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Human Drugs

Stakeholder Technical Issues with Ophthalmic Guide

Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations.

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Human Drugs

FDA Approves Neuroblastoma Drug

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

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Medical Devices

Update GAO Device Recall Oversight Report: Senators

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