As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally.

Stealth Biotherapeutics Corp.’s refusal to file (RTF) letter from the FDA regarding the NDA for elamipretide, a candidate that targets mitochondria in the treatment of Barth syndrome, hardly knocked the stock, as investors likely saw the bad news coming.

The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.

The FDA granted breakthrough device designation to Histosonics Inc. for the first system to harnesses microbubbles created by pulsed ultrasound waves to wreak very targeted cellular destruction, with real-time visualization and control. The therapy, called histotripsy, destroys tissue in the liver without heat, radiation or surgery. The technology was developed at the University of Michigan.

The question of bias in artificial intelligence (AI) algorithms is generally thought to be overcome by ensuring that the data set used to train the algorithm is representative of the population at large. However, Naomi Aaronson, executive director of clinical evaluation at the Blue Cross Blue Shield Association, said its not that simple because demographic data can combine in unpredictable ways and thus “the only real understanding of whether it works is in the clinical validation” of the algorithm in various settings.