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Medical Devices

FDA Emergency Use Authorization for Ventilators

FDA issues an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing de...

Human Drugs

Teva Says Copaxone Should Have a BLA

Teva sues FDA to force it to transition the NDA for Copaxone to a BLA as required under the Biologics Price Competition and Innovation Act.

Human Drugs

Innocoll NDA Resubmitted for Pain Product

FDA accepts an Innocoll Holdings NDA resubmission for post-surgical pain product Xaracoll (bupivacaine hydrochloride collagen-matrix implants).

Human Drugs

FDA OKs Xellia Pharma Cleveland Sterile Drug Plant

FDA approves Xellia Pharmaceuticals Cleveland, OH manufacturing site to make anti-infective drug products for the U.S. market.

Human Drugs

FDA Approves BMS Zeposia for Relapsing MS

FDA approves Bristol-Myers Squibbs Zeposia, a new oral treatment for relapsing multiple sclerosis.

Medical Devices

FDA OKs Somryst Prescription Digital Therapeutic

FDA authorizes Pears Somryst prescription-only digital therapeutic intended to treat chronic insomnia in adults age 22 and older.

Medical Devices

FDA Says Digital Health Policies Help Covid-19 Solutions

FDA says it does not regulate as medical devices many digital health solutions used by public health officials and the public to manage response to Co...

Medical Devices

Comments on AI Used in Radiological Imaging

FDA extends the comment period on a 2/25-26 public workshop on artificial intelligence in radiological imaging.

Human Drugs

FDA Ends Clinical Data Summary Pilot

CDER ends its clinical data summary pilot program.

Human Drugs

Stimulus Bill Includes New OTC Drug User Fees

The coronavirus-related economic stimulus legislation includes language to allow FDA to create a new user fee program for over-the-counter drugs.