USFDA

U.S. Food and Drug Administration’s comprehensive to regulate tobacco and nicotine first-and-foremost seeks to better protect our nation’s youth, as well as future generations, from the disease and death caused by tobacco use.

The U.S. Food and Drug Administration  issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The U.S. Food and Drug Administration authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants).

U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).

The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.

The U.S. Food and Drug Administration  approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples.

The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide.

U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. The agency protecting consumers of unapproved products claiming to prevent, treat or cure influenza, or flu.

In its continued efforts to protect consumers and ensure food safety, the U.S. Food and Drug Administration has begun testing fresh cilantro, parsley and basil, as well as processed avocado and guacamole, for certain microbial contaminants. These two large-scale sampling assignments will help the FDA assess the rates of bacterial contamination in these commodities, as well as help to identify possible common factors among the positive samples.

FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.