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SterRx Recalls 3 Sodium Bicarbonate Lots

[ Price : $8.95]

SterRx recalls three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamina...

Could Be Weeks Before FDA Chief is Named: CNN

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CNN reports it has been told by two administration officials that it could be weeks until a permanent FDA commissioner is named.

Ables Mach Screw Clip Cleared by FDA

[ Price : $8.95]

FDA clears an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device.

Single-use ENT Scope Cleared for Use

[ Price : $8.95]

FDA clears a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat Scope.

Lantern Orphan Status for Pancreatic Cancer Drug

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FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer.

FDA Seeks Consumer Reps for Advisory Panels

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...

Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement

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The Federal Circuit Court of Appeals says promotional materials developed by Teva were enough to induce infringement of a GSK carv...

Captains Cloth Selling Unapproved KN95 Masks: FDA

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FDA warns Captains Cloth it is marketing unapproved, adulterated, and misbranded KN95 face masks.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include BBC Group, Lepu Medical Technology and Sanit Technologies.

Panel to Discuss Cook Pediatric Esophageal Device

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Federal Register notice: FDA announces a 9/17 Pediatric Advisory Committee to discuss a pediatric-focused safety review of Cook Me...