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Medical Devices

Percussionaire Recalls Breathing Circuits

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

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Human Drugs

Opioid REMS to Require Mail-Back Envelopes

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

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Human Drugs

FDA Taps Comstock Rick for Rare Disease Hub

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

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Human Drugs

Aarti Drugs India Plant Hit with FDA-483

A recent inspection of Aarti Drugs Ltds active pharmaceutical ingredient manufacturing plant in India leads to a seven-item FDA Form-483.

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Human Drugs

Sen. Rubio Seeks to Ban Certain APIs from China

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

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Human Drugs

FDA: Compounders Should Use Suitable Ingredients

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

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Human Drugs

FDA Extends Some Baxter Parenteral Drug Product Use Dates

FDA announces extended use dates for some Baxter parenteral products to ease supply issues caused when a Baxter North Carolina facility was hit by Hur...

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Human Drugs

Warning on Skin-Cap Spray Products

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

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Human Drugs

Exactech 3D-Printed Knee Implant Cleared

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

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Human Drugs

Imbed Bio Lidocaine Wound Dressing Cleared

FDA clears an Imbed Biosciences 510(k) for its Microlyte Ag/Lidocaine, an antimicrobial wound dressing that integrates lidocaine for managing painful ...