FDA Related News

Oncology Drug Pilot on LDT Performance Criteria

Oncology Center of Excellence associate director Harpreet Singh describes a new pilot program to outline performance criteria for lab-developed biomar...

Medical Devices

Zyto Illegally Marketing Galvanic Skin Device: FDA

FDA issues a second Warning Letter to Zyto Technologies in Lindon, UT, about its illegal marketing of the Zyto galvanic skin response hand cradle and ...

Medical Devices

FDA Hernia Repair Surgical Mesh Info

FDA publishes an online page describing hernias and their repair, with attention to using surgical mesh in the repair.

Medical Devices

Draeger Recalls Ventilator Over Battery Issues

Draeger Medical recalls its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of...

Biologics

Cell, Gene Manufacturing Changes, Comparability

FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.

Human Drugs

Opill Approved as 1st OTC Oral Contraceptive

FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over...

Biologics

Dr. Reddys Rituxan Biosimilar BLA Accepted

FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.

Human Drugs

CGMP, Other Issues at NeilMed Pharmaceuticals

FDA warns Santa Rosa, CA-based NeilMed Pharmaceuticals about CGMP and other issues in its production of finished drugs.

Human Drugs

Disclose Drug, Supplement Animal Ingredients: Petition

VeganMed asks FDA to require drug and dietary supplement manufacturers to disclose in product labeling any animal-derived ingredients in their product...

Medical Devices

Boston Scientific Brain Stimulation Software OKd

FDA approves Boston Scientifics Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulation System for treat...