In response to the ongoing situation in Japan, the U.S. Environmental Protection Agency has taken steps to increase the level of nationwide monitoring of milk, precipitation, drinking water, and other potential exposure routes.
Category Archives: Drug Safety Information Podcasts
FDA Warns Consumers to Stop Using Soladek Vitamin Solution
The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.
Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.
FDA approves new treatment for a type of late-stage skin cancer
The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age
The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.
FDA: Michigan heart-lung bypass machine manufacturer enters into consent decree
The U.S. Food and Drug Administration today announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction.
FDA, EMA announce pilot for parallel assessment of Quality by Design applications
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.
FDA approves imaging agent for central nervous system scans
The U.S. Food and Drug Administration today approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.
Maryland sprout processor enters into consent decree with the FDA
The Food and Drug Administration announced today that Vegi-Pak Farm LLC of Mt. Airy, Md., and its president, Sun Ja Lee, and general manager, Brian W. Lee, signed a consent decree recently prohibiting them from processing, holding and distributing bean sprouts due to their failure to comply with federal food safety laws.
Vegi-Pak Farm grows, processes, packages and distributes ready-to-eat soybean sprouts and holds and distributes tofu and mung bean spouts. The products are sold to markets in Maryland, Virginia and Washington, D.C. DSK
FDA approves device to maintain blood flow during artery bypass brain surgery
The U.S. Food and Drug Administration today approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.
FDA, Justice Department take action against McNeil-PPC Inc.
The U.S. Food and Drug Administration announced today that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.