The Food and Drug Administration is proposing a system for approving customized drugs and medical treatments for patients with rare or hard-to-treat diseases. The pathway laid out Monday is aimed to approving one-of-a-kind therapies, including those using emerging gene-editing technology. It's a shift long sought by patients, advocates and researchers focused on rare diseases, which often do not fit within the pharmaceutical industry's business model. For many rare diseases, drug companies have had little financial incentive to develop new treatments. The FDA proposal, if finalized, would codify a path for drugmakers and researchers to study and commercialize treatments without conducting large, expensive clinical trials.
As mental health chatbots driven by artificial intelligence proliferate, a small number of states are trying to regulate them. Laws in Illinois, Nevada and Utah are among the first in the nation to put limits on or ban therapy chatbots. But app creators, policymakers and mental health advocates say it is just a start and federal regulation would be ideal. App makers worry the patchwork of laws could stifle innovation needed due to a nationwide shortage of human therapists. They also note that many of the laws don't cover generic chatbots like ChatGPT.
IV therapy clinics are springing up around the country, touting quick ways to recover from a hangover or a hard workout. But doctors and regulators preach caution before plunging into a visit. The service has been on a growth spurt since the COVID-19 pandemic, offering drips that also aim to boost energy levels or immune systems or deal with things like joint pain. Regulators worry about who delivers the treatments, the source of any pharmaceuticals used and how the services are provided. Customers should come prepared to ask questions before they get connected.
