FDA Related News

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.

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 ...

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.

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...

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.

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.

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 ...

Use Risk-Based AI/ML Regulation: AstraZeneca

AstraZeneca provides four comments to the FDA docket on considerations for generative artificial intelligence/machine learning over a medical devices ...

Medical Devices

Datex-Ohmeda Recalls Giraffe OmniBeds

GE HealthCare subsidiary Datex-Ohmeda recalls its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions.

Human Drugs

UCBs Bepranemab Misses Primary Endpoint

UCB says its investigational Alzheimers drug bepranemab missed the primary endpoint in a Phase 2a trial but hit secondary endpoints in some patient su...