FDA Tagged Articles
FDA bans the sale and distribution of four tobacco products by Jash International
Utilizing its new authority under the Family Smoking Prevention and Tobacco Control Act, the U.S. Food and Drug Administration (FDA) has ordered the sale and distribution of four tobacco products on the market to end.
Medicine safety will be the topic of interest for the FDA and the EMA’s recent cluster formation
A new ‘cluster’ on pharmacovigilance (medicine safety) topics has been established by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Used to foster communication between the EMA and regulators outside of the European Union, clusters are
Uncle Ben’s Infused Rice products recalled after students, faculty experience strange side-effects
Students in Texas, Illinois and North Dakota experienced rashes, burning and nausea after eating Uncle Ben’s Infused Rice, leading to a recall of all Uncle Ben’s Infused Rice products by Mars Inc.
FDA reassessing testosterone drug safety
The U.S. Food and Drug Administration (FDA) said it plans to review the safety of testosterone replacement drugs after two separate studies indicated a higher risk of adverse cardiac events in men who used the products, including one report that
FDA’s “The Real Cost” campaign will be the first of many aimed at reducing teen tobacco use
In an effort to prevent youth tobacco use and reduce the number of regular teen smokers, the U.S. Food and Drug Administration (FDA) announced the launch of a new national public education campaign by the name of “The Real Cost”
Direct-to-consumer advertising likely inflating demand for testosterone drugs, new study finds
Testosterone replacement therapy for men increased in the U.S. and the U.K. between 2000 and 2011, but whereas supplementation rates quadrupled in the U.S. during that time, they rose just 30 percent in the U.K., according to a new study
Studies reveal not all FDA-approved drugs and medical devices receive adequate testing
According to articles in the Journal of the American Medical Association (JAMA), there can be major discrepancies in the amount of testing medical devices and drugs go through before being approved or given to patients.
FDA considering whether to expand usage of cholesterol medication Vascepa
The Food and Drug Administration (FDA) is considering a proposal by biopharmaceutical company Amarin to expand the indication for Vascepa, a prescription-strength fish-oil pill designed to lower triglyceride levels in patients with high cholesterol.
Collaborative generic drug inspections initiative launched by FDA and European Medicines Agency
A joint initiative was launched Dec. 18 by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to share information on examinations of bioequivalence studies in support of generic drug approvals. The agencies will work in
FDA focusing on the long-term safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration (FDA) decided that antibacterial hand soaps and body wash manufacturers would be required to prove the long-term effectiveness and safety of their products against the usage of just basic soap and water. Companies that