Posts Tagged ‘FDA’


Sunday, October 29th, 2017

The Food and Drug Administration recently approved a trial to use adipose-derived stem cells to treat non-healing leg ulcers, a common complication of diabetes, in a study conducted by researchers at Sanford Health.  “This clinical trial can help explore treatments for people with non-healing wounds, including people who have diabetes and others with conditions that affect their quality of life,” according to David Pearce, Ph.D., executive vice president of innovation and research at Sanford Health. According to the World Health Organization, in 2014 more than 422 million people have been living with diabetes globally.  The trials, which began in September, followed a similar study in which stem cells were tested for the treatment of shoulder injuries.

While the study has not yet been completed, the FDA’s support indicates growing interest in this arena.  According to Marissa Brassfield of Abundance 360, “this is a great example of how we can use exponential technology advances to tackle large-scale problems — like the 2 to 5 million people living with chronic wounds in the United States alone — which serves to fund a larger vision, refine the technical details, and explore adjacent applications.”


Tuesday, October 3rd, 2017

Drug manufacturer, Allergan, announced the FDA approval of BOTOX Cosmetic (OnabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines.  This is the third approval awarded to the BOTOX brand of neurotoxin, which had previously been approved only for the cosmetic treatment of crow’s feet and glabellar (“elevens”) lines. While the approval comes as no surprise to most Undercover Agents, it is surprising to learn that BOTOX Cosmetic is the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines in the U.S. (competitors, Dysport and Xeomin, are more limited in their FDA-approved uses).

“Allergan recognizes that forehead lines are a top area of concern for patients,” says David Nicholson, Chief Research and Development Officer at Allergan. “Our goal in pursuing a third indication for BOTOX Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes.”  Approved for use in over 75 countries, BOTOX Cosmetic is the most widely researched and studied treatment of its kind.


Tuesday, September 26th, 2017

A federal judge ordered Flawless Beauty LLC, who has sold injectable skin whitening and other beauty products, to stop selling and recall some of its products.  According to the complaint for permanent injunction, filed on the FDA’s behalf, Flawless Beauty sold unapproved and improperly labeled (misbranded) drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products.  Intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks. The company also sold several products that are labeled to contain human placenta, which can result in serious illness.  Some of the products sold by Flawless Beauty also implied FDA approval or endorsement, which the company did not have.

“Despite repeated warnings, Flawless Beauty continued to put patients at risk by selling potentially dangerous and unproven treatments to consumers,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge consumers to beware of these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products.”