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Contract Manufacturing Quality Agreement Guidance

[ Price : $8.95]

FDA issues a guidance on agency thinking on quality agreements in contract manufacturing arrangements.

FDA Nixes Additional Risk-based BE Testing Actions

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FDA says its activities in soliciting comment on bioequivalence testing methodologies are sufficient and no additional activities ...

Is Trump Looking at Pences Health Commissioner for HHS Role?

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President-elect Donald Trump meets with Indiana state health commissioner Jerome Adams, presumably as a candidate for HHS secretar...

Intarcia Therapeutics NDA Filed for Type Diabetes Therapy

[ Price : $8.95]

Intarcia Therapeutics files an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes.

Reg Review Period on Medtronics Core Valve System

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Federal Register Notice: FDA determines the regulatory review period for Medtronics Core Valve System for patent extension purpose...

Reg Review Period on Pharmings Ruconest

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Federal Register Notice: FDA determines the regulatory review period for Pharming Groups Ruconest for patent extension purposes 3...

Reg Review Determination on Celegenes Cerdelga

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Federal Register Notice: FDA determines the regulatory review period for Celgenes Cerdelga (eliglustat) for patent extension purpo...

Draft Guide on Pediatric Clinical Trials

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Federal Register Notice: FDA makes available a draft guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Produ...

5 Off-label Communication Hearing Themes

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Mintz Levin attorneys summarize five important themes from an FDA hearing on appropriate regulation of off-label communication.

CP Pharmaceuticals Inspection Found CGMP Issues

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FDA warns CP Pharmaceuticals about CGMP violations in its manufacture of finished pharmaceuticals.