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NECC Targeted in Grand Jury Probe: Newspaper

[ Price : $8.95]

A Boston newspaper reports that New England Compounding Center is the target of a federal grand jury investigation into its role a...

Info on IDE Reports Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on investigational device exemptions reports and records...

Comments Sought on Antiparasitic Drug Info

[ Price : $8.95]

Federal Register Notice: FDA seeks comment on the collection of information for its antiparasitic drug and resistance survey.

CDER Guidance on PET Drugs and IND Process

[ Price : $8.95]

A new CDER guidance summarizes the IND process for positron emission tomography drugs, and provides advice on investigational PET ...

FDA, Device Industry Collaborate on Regulatory Science

[ Price : $8.95]

FDA announces the creation of the first public-private partnership intended to promote medical device regulatory science.

FDA Clears AliveCor App for iPhone Heart Monitor

[ Price : $8.95]

FDA clears an AliveCor 510(k) for its Heart Monitor, a mobile ECG device, compatible with the iPhone 4 and 4S models.

Verathon Recalls GlideScope Video Laryngoscope Blades

[ Price : $8.95]

Verathon recalls its GlideScope GVL Video Laryngoscope reusable blades manufactured between 12/2010 and 8/2011 because they have b...

Endo Sues FDA Over Opana ANDAs

[ Price : $8.95]

Endo Pharmaceuticals sues FDA seeking declaratory and injunctive relief that will effectively block generic copies of Opana ERs no...

Biosimilar Paper Urges Distinct Naming Process

[ Price : $8.95]

A whitepaper from the Alliance for Safe Biologic Medicines (ASBM) urges FDA to require that all biosimilar and biologic products b...

Class 1 Recall of Mindray Anesthesia Devices

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FDA says Mindray has begun a Class 1 recall of its Mindray A3 and A5 Anesthesia Delivery System.