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FDA Clears Alcyone Lifesciences Alivio System

[ Price : $8.95]

FDA clears an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus.

Ultragenyx NDA for Mepsevii OKd for Rare Metabolic Condition

[ Price : $8.95]

FDA approves an Ultragenyx Pharmaceutical NDA for Mepsevii (vestronidase alfa-vjbk), the first approved treatment for pediatric an...

FDA Seeking to Improve Hiring Process for New Staff

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FDA commissioner Scott Gottlieb announces a 2018 pilot project to evaluate efforts to make the agency hiring process more efficien...

FDA Authorizes Cancer Tumor Profiling Test

[ Price : $8.95]

FDA releases the 2015 National Antimicrobial Resistance Monitoring System (NARMS) report showing some gains in reducing antibiotic...

CGMP Violations Found in 2 Lupin Facilities

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FDA warns Indias Lupin Limited about repeat CGMP violations at its drug manufacturing facilities in Goa and Indore.

Issues Found in TV Ad Major Statements: Study

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FDA advertising researchers say that drug companies still are not following recommendations from previous studies to improve commu...

FDA Approves 1st Digital Tracking Medicine

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FDA approves an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) the firs...

Safety Alert on Silicone Marketed as Body Contouring Product

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FDA issues a safety alert about illegal use of injectable silicone for body contouring and associated injuries and disfigurement t...

Class 2 for Indirect Immunofluorescence Microscope

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Federal Register notice: FDA classifies the automated indirect immunofluorescence microscope and software-assisted system into Cla...

Companies Making Cybersecurity Progress: Schwartz

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CDRH associate director Suzanne Schwartz praises the progress medical device manufacturers have made in addressing cybersecurity i...