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FDA Approves Medtronic Enlite Sensor for Glucose Monitor

[ Price : $8.95]

FDA approves a Medtronic PMA for the Enlite sensor for use with iPro2 Professional Continuous Glucose Monitoring system.

FDA Tentative Approval for Perrigo Epiduo

[ Price : $8.95]

FDA grants Perrigo tentative ANDA approval for a generic version of Gladermas Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%...

FDA Accepts Array Bio NDA for Melanoma Drug

[ Price : $8.95]

FDA accepts for review an Array BioPharma NDA for binimetinib for treating certain patients with melanoma.

FDA Safety Alert on Sciex Mass Spectrometers

[ Price : $8.95]

FDA issues a safety alert for lab staff and health care professionals about a software defect in Sciex mass spectrometers.

FDA Renews Cardiovascular and Renal Drugs Advisory Panel

[ Price : $8.95]

Federal Register Notice: FDA renews the charter of the Cardiovascular and Renal Drugs Advisory Committee for an additional two yea...

FDA Renews Endocrinologic and Metabolic Panel

[ Price : $8.95]

Federal Register Notice: FDA renews the charter of the Endocrinologic and Metabolic Drugs Advisory Committee.

FDA Plans Workshop on Immunization Monitoring

[ Price : $8.95]

Federal Register Notice: FDA plans a workshop The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program to ...

Integrity Agreement for Device Company in Kickback Scheme

[ Price : $8.95]

The HHS Office of Inspector posts a corporate integrity agreement between the government and Minneapolis-based Cardiovascular Syst...

Draft Elemental Impurities Guidance Needs Update: Glaxo

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Three stakeholders ask for clarifications in an FDA draft guidance on drug product elemental impurities.

FDA Schedules Sentinel PRISM 12/7 Workshop

[ Price : $8.95]

FDA schedules a workshop on its PRISM vaccine evaluation program that is part of the Sentinel Initiative.