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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

[ Price : $8.95]

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

Reg Review Period on Pharmings Ruconest

[ Price : $8.95]

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

Reg Review Determination on Celegenes Cerdelga

[ Price : $8.95]

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Federal Register Notice: FDA makes available a draft guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Produ...

CGMP Violations at Indias Srikem Laboratories

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FDA warns Indias Srikem Laboratories about CGMP violations and data integrity issues in its manufacturing of active pharmaceutical...

2 Sunscreen Guidances Published

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FDA issues two guidances on GRASE determinations for OTC sunscreen products.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites NutriResearch, Pine Pharmaceuticals, Physician Therapeutics, Srikem Laboratories...

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

[ Price : $8.95]

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