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FDA Reconsiders CAR-T Product Warning: Marks

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FDA backpedals on safety warnings it required on CAR-T cell therapies related to secondary cancers, according to CBER director Pet...

Percussionaire Recalls Breathing Circuits

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Percussionaire recalls certain lots of its Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one ...

Opioid REMS to Require Mail-Back Envelopes

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FDA approves the addition of mail-back envelopes to the existing opioid analgesic risk evaluation and mitigation strategy to help ...

FDA Taps Comstock Rick for Rare Disease Hub

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FDA brings on former Leavitt Partners consultant Amy Comstock Rick to serve as strategic coalitions director for the newly created...

Aarti Drugs India Plant Hit with FDA-483

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A recent inspection of Aarti Drugs Ltds active pharmaceutical ingredient manufacturing plant in India leads to a seven-item FDA Fo...

Sen. Rubio Seeks to Ban Certain APIs from China

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Senator Marco Rubio (R-FL) urges FDA to take immediate action against two pharmaceutical companies based in Chinas Xinjiang region...

FDA: Compounders Should Use Suitable Ingredients

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FDA reminds drug compounders to only use ingredients that are suitable for compounding drugs intended to be sterile.

FDA Extends Some Baxter Parenteral Drug Product Use Dates

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FDA announces extended use dates for some Baxter parenteral products to ease supply issues caused when a Baxter North Carolina fac...

Warning on Skin-Cap Spray Products

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FDA warns that Chemigroup France is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids.

Exactech 3D-Printed Knee Implant Cleared

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FDA clears an Exactech 510(k) for the Truliant Porous Tibial Tray, a 3D-printed tibial knee implant.