FDA Related News

Human Drugs

FDA Releases 2018 Compounding Policy Priorities Plan

FDA releases its 2018 compounding policy priorities plan focusing on five areas related to drug compounding.

Delay in Implementing New Human Subject Protections

Sixteen federal agencies announce a six-month delay in implementation of new provisions for protection of human subjects while information and comment...

Human Drugs

AuroMedics Levofloxacin Recall

FDA says AuroMedics Pharma is recalling one lot of levofloxacin 5% dextrose injection that may contain mold.

Human Drugs

Half of FDA Employees Likely to Stay Home Under Shutdown

A government shutdown over the current budget impasse threatens almost half of FDA employees, who would be ordered to stay home.

Medical Devices

FDA Clears International Biophysics Heart Pump

FDA clears an International Biophysics 510(k) for the FloPump 32 centrifugal disposable heart pump.

Medical Devices

Medtronic Riptide Aspiration System Cleared by FDA

FDA clears a Medtronic 510(k) for the Riptide Aspiration System for use in retrieving blood clots through the Arc catheter and restoring blood flow in...

FDA Wants Regulatory Science Collaborators

Three FDAers call for academic and industry scientists to join with agency efforts to conduct research supporting regulatory science.

FDA General

Committee Recommends Azar to Senate for HHS Vote

The Senate Finance Committee recommends on a 15-12 vote that the full Senate approve the nomination of Alex Azar as HHS secretary.

Medical Devices

FDA Warns on Zoll LifeVest Wearable Defibrillator

An FDA safety alert warns health professionals about Zoll Medicals Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that the dev...

Human Drugs

Priority Review for Novartis sBLA for Kymriah

FDA accepts for priority review a Novartis supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for t...