The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the manufacturer’s intended use. While the final rule says that mere knowledge of off-label use cannot be the sole determinant of the manufacturer’s intended use, the rule still allows the FDA to infer intended use by “any relevant source of evidence,” a term that may be sufficiently squishy to be functionally equivalent to the controversial totality-of-the-evidence standard.

Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.

China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards.

Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.

Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication.

The FDA’s device center has a mantra of sorts when it comes to the details, or lack thereof, in guidance, which is “talk to us early and often.” For device makers eyeing the brain-computer interface (BCI) device space, this mantra has been applied to the question of pivotal study enrollment numbers, suggesting that some sponsors will find their pivotal studies come with a case of sticker shock sufficient to force them to rethink their research and developmental plans.

Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.