Category Archives: Drug Safety Information Podcasts

FDA orders postmarket surveillance of certain TMJ implants

February 8, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

TMJ, postmarket, surveillance

FDA approves drug to reduce risk of preterm birth in at-risk pregnant women

February 4, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

FDA clears first diagnostic radiology application for mobile devices

February 4, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

iPhone, iPad, radiology

FDA reminds health care professionals about safe use of non-sterile alcohol prep pads

February 2, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

Following a recent recall of potentially contaminated non-sterile alcohol prep pads, the U.S. Food and Drug Administration today reminded health care professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.

Fourth FDA orphan drug designation workshop scheduled for Feb. 28 – March 1, 2011

January 28, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 – March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute.

FDA review indicates possible association between breast implants and a rare cancer

January 26, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

ALCL, breast implants

FDA approves Viibryd to treat major depressive disorder

January 22, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

Vlibryd, depressive disorder

Maine seafood processor enters into consent decree with FDA

January 20, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

The U.S. Food and Drug Administration announced today that the Portland Shellfish Co., Inc.; Jeffrey D. Holden, company president; Satyavan Singh, quality manager; and John A. Maloney, general manager, have signed a consent decree prohibiting them from distributing seafood in interstate commerce until the FDA has approved in writing the company’s Hazard Analysis and Critical Control Point (HACCP) plans, sanitation program and Listeria monocytogenes (L. mono) testing program. (DSK)

FDA Approves Head Lice Treatment for Children and Adults

January 19, 2011Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

FDA to improve most common review path for medical devices