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CGMP Violations Found in 2 Lupin Facilities

[ Price : $8.95]

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...

No FDA-Approved Products with Kratom: Gottlieb

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FDA commissioner Scott Gottlieb cautions that the agency has not approved any products containing kratom and is taking action agai...

Ways to Improve FDA Unapproved Drugs Initiative

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Researchers suggest ways to improve generic competition for previously unapproved drugs that have gained FDA approval under the ag...

Multiple Violations Found at RTI Surgical

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FDA warns RTI Surgical about multiple violations in its continuing manufacture of a bone graft product that is regulated as a drug...

Prostatic Artery Embolization Device into Class 2

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Federal Register notice: FDA classifies the prostatic artery embolization device into Class 2 (special controls).