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FDA Clears RenovoRx RC120 Catheter

[ Price : $8.95]

FDA clears a RenovoRx 510(k) for its RenovoCath RC120 catheter, intended for isolating blood flow and delivering fluids.

FDA Grants Fast Track on Novavax Vaccine

[ Price : $8.95]

FDA grants Novavax a fast track designation for its H7N9 virus-like particle vaccine candidate (H7N9 VLP) adjuvanted with Matrix-M...

Data Sharing in Medical Product Development

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A Georgetown University report promotes voluntary data sharing as a way to benefit medical product development.

FDA Approves AstraZenecas Xigduo XR for Diabetes

[ Price : $8.95]

FDA approves an AstraZeneca NDA for once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for treating...

Biosimilar Patent Dance Problems Seen: Attorney

[ Price : $8.95]

Attorney Kurt Karst says an Amgen complaint against Sandoz over a biosimilar version of Neupogen is demonstrating difficulties fou...

Many Laws, Regulations Affect mHealth Devices: Lawyers

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A Foley & Lardner online report says developers of mHealth mobile technologies must be aware of the many laws and regulations that...

More Criticism of Risk Info Guidance

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Public comments continue to criticize an FDA draft guidance on disseminating risk information to healthcare providers for either v...

Petition Seeks Cipro Indication Restrictions

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A citizen petition asks FDA to order extensive prescribing limitations for Cipro due to adverse events seen in post-marketing expe...

Suggestions Made for Informed Consent Guidance

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Stakeholders say an FDA draft guidance on the informed consent information sheet may lead to a document that is too complex for ma...

Bill to Speed Ebola Treatments Coming

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Sens. Harkin and Alexander say they will introduce legislation to add Ebola to the list of qualifying tropical diseases for an FDA...