FDA Related News

Human Drugs

FDA Denies Persion Zohydro ER Petition

FDA denies a Persion petition asking that it restrict ANDA approval for generic products citing Zohydro ER as the reference-listed drug.

Human Drugs

15 Potential Signals of Risk, New Safety Info

FDA releases a list of 15 potential drug safety signals that occurred in the fourth quarter of 2019.

Human Drugs

Sarepta Again Works Appeals Magic to Win Approval

Just-released approval documents shed light into how Sarepta was able to again win FDA approval for a Duchenne muscular dystrophy (DMD) drug after bei...

Patient Service Inc. Settles Kickback Case for $3 Million

The Justice Department says Patient Services Inc. is paying $3 million to resolve false claims allegations that it coordinated with three drug compani...

Medical Devices

FDA Clears Teleflex Pacing Guidewire

FDA clears a Teleflex 510(k) for the Wattson Temporary Pacing Guidewire, a bipolar device designed for use during transcatheter aortic valve replaceme...

2 Former Insys Execs Sentenced Over Opioids

Two former Insys sales executives are sentenced to federal prison sentences for their role in a bribery and kickback scheme to promote use of the comp...

Medical Devices

Medtronic Smallest Pacemaker w/AV Synchrony OKd

FDA approves a Medtronic PMA for the Micra AV, which it describes as the worlds smallest pacemaker with atrioventricular synchrony.

Human Drugs

Zhuhai Aofute Medical Technology CGMP Violations

FDA warns Chinas Zhuhai Aofute Medical Technology Co. about CGMP and other violations in its manufacturing of finished drugs.

Human Drugs

FDA Launching Drug Risk Management Board

CDER launches its Drug Risk Management Board to facilitate rapid analysis and resolution of drug safety issues throughout the Center.

Medical Devices

Clinical Performance Assessment Guidance

FDA publishes a guidance on computer-assisted detection devices applied to radiology images and radiology device data.