�������ýҕ�l

U.S. regulators will soon begin cracking down on vaping companies using a now-closed loophole, including a line of fruit-flavored e-cigarettes that have become teenagers’ top choice. Under a law taking effect [April 14], the Food and Drug Administration can regulate e-cigarettes and similar products that use synthetic nicotine. The action targets Puff Bar and several other vaping companies that recently switched their formulas to laboratory-made nicotine to skirt FDA oversight. (Perrone, 4/14)

While the measure doesn’t outlaw synthetic nicotine products automatically, companies are now required to register with the FDA and submit their products for review within 30 days. The new law also subjects synthetic nicotine products to the same age limit and sales restrictions as natural tobacco products. (Robinson, 4/16)

COVID-19 vaccine technology doesn’t just fight viruses – it can combat cancer. Duke researchers find potential in a cancer vaccine based on the same messenger RNA, or mRNA, technology used by COVID-19 vaccines to combat a type of breast cancer that over expresses a protein called HER2, according to a recent Fox 8 report. "It is a product which is RNA nucleic acid which encodes a specific protein and then that can be encapsulated in something we like to call a lipid nanoparticle, which is really a little fat bubble, and that can be injected into your body and sort of teaches your body what to go after immunologically," said Dr. Zachary Hartman, assistant professor in the departments of surgery, pathology, and immunology at Duke University School of Medicine. (Sudhakar, 4/16)

Addiction treatment providers scrambled at the start of the coronavirus pandemic to find ways to keep people engaged after they shut their physical doors. For most, that meant telehealth, or audio or video calls. But with fatal overdoses spiking in Maryland and nationally, leaders of the Center for Addiction Medicine at the University of Maryland Medical Center Midtown Campus turned to an extra measure that is turning into a bright spot in their efforts. It’s a mobile app they began testing about a year ago specifically for those with opioid use disorders. Called reSET-O, it’s for those being treated for opioid use. Another called reSET is for those being treated for use of alcohol and other substances. They were the first prescription apps approved by the U.S. Food and Drug Administration for substance use disorders, in 2018 and 2017, respectively. (Cohn, 4/18)

Since launching in 2017, an ambitious and secretive Food and Drug Administration program to speed up medical device development has helped at least 44 authorized devices hit the market. There are now more than 650 devices that have earned “breakthrough designation,” a signal that the agency believes — based on early data and the options currently available to patients — that a product could one day be “more effective” at treating or catching serious or even fatal conditions. STAT has identified details on more than two-thirds of those products in an authoritative new database, the Breakthrough Device Tracker. (Palmer and Aguilar, 4/18)

Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices, all in the name of getting them to patients faster. The initiative, known as the Breakthrough Devices Program, was set up to identify devices that the agency believed could provide “more effective” treatment or diagnosis for deadly and debilitating conditions than the current standard of care. And it came with perks: Among them, manufacturers of devices that receive the designation — more than 650 products so far — are given the opportunity to talk more often with regulators and design flexible clinical trials, potentially easing the path to market. But a STAT investigation has found that while the program has delivered big benefits to companies making devices, its value to patients is still far from clear. (Palmer and Aguilar, 4/18)