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Alkermes sNDA for Aristada New Dosing Interval

[ Price : $8.95]

Alkermes files a supplemental NDA for a two-month dosing interval for Aristada (aripiprazole lauroxil) extended-release injectable...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Adamson Analytical Laboratories, Concept Products, Fallon Wellness Pharmacy, Fin...

Panel to Discuss Wound Care Product Dressing

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Federal Register Notice: FDA plans a meeting of the General and Plastic Surgery Devices Panel 9/20-21.

Panel to Consider OTC Infectious Disease Tests

[ Price : $8.95]

FDAs Microbiology Devices Panel will consider OTC diagnostic devices for three infectious disease pathogens.

CGMP Violations at Adamson Analytical Labs

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FDAs Los Angeles District Office warns Adamson Analytical Laboratories about violations of CGMP regulations for finished pharmaceu...

Wide Variance in FDA Subpart H Approvals: Attorneys

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Two Hyman, Phelps & McNamara lawyers say FDA is exercising more regulatory flexibility than is given to it when making accelerated...

FDA Draft Guidance on Ulcerative Colitis Trial Endpoints

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FDA posts a draft guidance on Ulcerative Colitis: Clinical Trial Endpoints that is intended to assist sponsors in their clinical d...

New Report Shows Industry Struggling to Meet UDI Compliance

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A new report indicates that many medical device makers are not ready to implement Unique Device Identification labeling based on F...

FDA Accelerated Approval for Mercks Keytruda in Head/Neck Cancer

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FDA grants Merck accelerated approval for Keytruda (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy for certia...

FDA Cites duPont Hospital for Pharmacy Compounding

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FDA cites Alfred I. duPont Hospital for Children after an inspection of its sterile drug compounding operations found significant ...