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FDA Sees Battery Problems in Some St. Jude Devices

[ Price : $8.95]

FDA and St. Jude Medical say that batteries on some defibrillators may drain quickly after signaling the patient that the battery ...

Guidance on Sunscreen Advisory Panel Process

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process for panel...

Guidance on Withdrawing Sunscreen Determination Requests

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance on Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Reque...

OTC Blood Glucose Monitor Guidance

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Self-Monitoring Blood Glucose Test Systems for Over- the-Counter ...

FDA Clears St. Judes PressureWire Guidewire

[ Price : $8.95]

FDA clears a St. Jude Medical 510(k) for the PressureWire X Guidewire fractional flow reserve measurement system, which is designe...

Petition Seeks Action Against MRI Accessories

[ Price : $8.95]

A citizen petition from the law firm Wood, Herron & Evans urges FDA to detain Magnacousticss MagnaTouch MRI Music System, Genesis ...

FDA Guidance on Sunscreen Advisory Panels

[ Price : $8.95]

FDA posts a guidance on Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process for panels convened to determine whet...

Lundbeck Wins OK for Carbamazepine I.V. Formulation

[ Price : $8.95]

FDA approves Lundbecks Carnexiv (carbamazepine) injection as a short-term replacement therapy for an oral carbamazepine formulatio...

FDA Clears Teleflex Arrow JACC Catheter

[ Price : $8.95]

FDA clears a Teleflex 510(k) to market its Arrow JACC with Chlorag Technology and TightTrack tunneler, a small french-size antithr...

Coalition Seeks Guidance on Clinical Decision-Support Software

[ Price : $8.95]

Clinical Decision Support Coalition calls on FDA to stop delaying a a much-needed and supposedly top priority guidance on clinic...