FDA Related News

Human Drugs

Biogen Gains Vumerity Approval for MS

FDA approves a Biogen NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis.

Medical Devices

Breakthrough Status for Enhanced Pulse Oximeter

FDA grants Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter), a wrist-worn arousal device designed to prevent res...

Medical Devices

Impulse Dynamics New Optimizer Smart System OKd

FDA approves an Impulse Dynamics PMA supplement for its next generation of the implantable Optimizer Smart System for delivering cardiac contractility...

Medical Devices

FDA Flexible in Weighing Medical Device Uncertainty

CDRHer Charles Viviano explains on a Webinar a new guidance on how the Center is flexible in weighing uncertainty in making medical device benefit-ris...

Medical Devices

Ethicon Echelon Flex Stapler Recall is Class 1

FDA says an Ethicon recall of its Echelon Flex staplers is Class 1.

Human Drugs

Woodcock Pushes Advanced Drug Manufacturing Technologies

CDER director Janet Woodcock says advanced manufacturing technologies could reduce U.S. drug maker reliance on foreign-sourced active pharmaceutical i...

Federal Register

FDA Withdrawing Watson Labs Oxycodone Hydrochloride

Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen tablets and is anno...

Federal Register

FDA Withdrawing InvaGen Trandolapril ANDA

Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.

FDA Regenerative Medicine Framework is Important Step: Pew

A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says much more needs to ...

Human Drugs

Court Rejects Innovator Liability in Generic Drug Case

Washington Legal Foundation reports on an Idaho state court decision that rejected the legal theory that a branded drug company can be held liable for...