USFDA

The U.S. Food and Drug Administration posted warning letter  issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA’s labeling tools to foster innovation toward healthier foods that consumers want is one of the primary goals of the FDA’s Nutrition Innovation Strategy that I first announced in March.

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

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The U.S. Food and Drug Administration is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research, whenever possible.

The aim is this: by doing a single study to help establish a non-animal based model, it can potentially replace much of the need to use dogs in future trials with new informatics tools. The  goal is to do one single study involving a small number of dogs—where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial—to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.

The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) released new findings from the National Youth Tobacco Survey (NYTS) showing that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018, a dramatic increase of more than 1.5 million students since last year. The sharp rise in e-cigarette use has resulted in an increase in overall youth tobacco product use, reversing a decline seen in recent years, and is prompting a series of steps by the FDA to curb youth use trends.

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues.

U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.

U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).