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7 Acne Products Recalled for Benzene: FDA

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FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possi...

Regulate NarxCare as Software as Medical Device: Petition

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The Doctor Patient Forum petitions FDA to regulate Bamboo Healths NarxCare platform and other prescription drug monitoring program...

Merck Reports Positive Data on HIV Trials

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Merck says it will seek FDA approval for new HIV regimen following its announcement of positive results from two pivotal Phase 3 t...

DoJ Lawyer Tapped as FDA Chief Counsel

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HHS appoints Justice Department attorney Hilary Perkins to serve as FDA chief counsel.

J&Js Monarch Quest Bronchoscopy Navigation Cleared

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FDA clears a Johnson & Johnson MedTech 510(k) for its Monarch Quest, an advanced navigation technology for robotically assisted br...

Comments Reopened on Good Clinical Practice Guide

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Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.

Priority Review for DMD Cardiomyopathy BLA

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FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy c...

Zenrelia Promotions False and Misleading: FDA

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FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representati...

FDA Safety Alert on Immune Globulin Products

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An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products...

CGMP Deviations at Shree Jaya Unit

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FDA warns Indias Shree Jaya Laboratories about CGMP deviations in its production of active pharmaceutical ingredients at a facilit...