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REMS Document Format, Content Guidance

[ Price : $8.95]

FDA publishes a guidance on the format and content for the REMS document portion of a REMS submission.

Arrow MAC Venous Access Kit Recall is Class 1

[ Price : $8.95]

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

Arrow Intra-Aortic Balloon Pump Recall is Class 1

[ Price : $8.95]

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

Latest Potential Signals of Serious Drug Risks

[ Price : $8.95]

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

Drug Companies Expected to Hike Prices

[ Price : $8.95]

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

Vivos Gets Sleep Apnea Device Cleared

[ Price : $8.95]

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

Consider Oncology Single-Arm Trial Issues: CDER

[ Price : $8.95]

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

FTC Updates Health Products Compliance Guide

[ Price : $8.95]

Attorney Phyllis Marcus says an updated Federal Trade Commission compliance guidance covers dietary supplements and adds many addi...

CGMP Deviations Found at MD Pharmaceutical Supply

[ Price : $8.95]

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

FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study

[ Price : $8.95]

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