FDA Related News

Medical Devices

Arrow MAC Venous Access Kit Recall is Class 1

FDA says the Teleflex recall of some Arrow MAC venous catheter kits is Class 1.

Medical Devices

Arrow Intra-Aortic Balloon Pump Recall is Class 1

FDA says the Arrow International recall of some intra-aortic balloon pumps for battery depletion issues is Class 1.

Human Drugs

Latest Potential Signals of Serious Drug Risks

FDA posts the latest three months of potential signals of serious risks/new safety information for prescription drug products.

Human Drugs

Drug Companies Expected to Hike Prices

Reuters reports that several major drug companies are expected to raise list prices on some 350 drugs this month.

Medical Devices

Vivos Gets Sleep Apnea Device Cleared

FDA clears a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea and snoring in adults.

Human Drugs

Consider Oncology Single-Arm Trial Issues: CDER

CDER researchers discuss some of the challenges in using single-arm trials to support the approval of oncology drugs.

Human Drugs

FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study

Bluebird Bio says it is working to resume enrollment and treatment of patients ages 2-17 in a lovo-cel sickle cell clinical trial after FDA lifts a pa...

FTC Updates Health Products Compliance Guide

Attorney Phyllis Marcus says an updated Federal Trade Commission compliance guidance covers dietary supplements and adds many additional health-relate...

Human Drugs

CGMP Deviations Found at MD Pharmaceutical Supply

FDA warns Hanover, PA-based MD Pharmaceutical Supply about CGMP deviations in its drug repackaging and relabeling operations.

Human Drugs

CGMP Deviations at Brazils Nortec Quimica

FDA warns Brazils Nortec Quimica about CGMP deviations in its production of active pharmaceutical ingredients.