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Medtronic Recalls TurboHawk Atherectomy System

[ Price : $8.95]

Medtronic recalls its TurboHawk Plus Directional Atherectomy System because it is similarly designed as another recently recalled ...

FDA Panel Reviewing PI3K Inhibitor Concerns

[ Price : $8.95]

FDA steps up its review of phosphatidylinositol-3-kinase (PI3K) inhibitor safety concerns by convening a 4/21-22 Oncologic Drugs A...

Quality Metrics Comments Sought on New Direction

[ Price : $8.95]

Federal Register notice: FDA creates a docket to receive comments on changes to the agencys previously proposed quality metrics re...

FDA, Industry Agree on MDUFA 5: RAPS

[ Price : $8.95]

The Regulatory Affairs Professional Society says FDA and medical device industry representatives have reached an agreement on MDUF...

Cionic Leg Neural Sleeve Cleared for Improved Mobility

[ Price : $8.95]

FDA clears a Cionic 510(k) for its lightweight leg-worn Cionic Neural Sleeve, intended for functional electrical stimulation to as...

Former FDAer Joins Hogan Lovells

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Hogan Lovells hires former FDAer Ryan Foringer as a senior regulatory specialist.

Spending Bill Gives FDA $102 Million Boost

[ Price : $8.95]

House and Senate appropriators come to terms to give FDA a $102 million (3.2%) boost to its discretionary funding for fiscal year ...

Sanofi/Sobi Plan BLA on Improved Factor VIII

[ Price : $8.95]

Sanofi and partner Swedish Orphan Biovitrum plan FDA submission after announcing positive topline results from the pivotal XTEND-1...

Quality System and Other Issues in CardioQuip Inspection

[ Price : $8.95]

FDA warns College Station, TX-based CardioQuip about multiple violations in its manufacture of a cardiac heater-cooler device in v...

FDA Withdraws Potassium Aminobenzoate Products

[ Price : $8.95]

Federal Register notice: FDA announces that all outstanding hearing requests regarding certain potassium aminobenzoate products ha...