Expect to see a slew of new software programs and tools aimed to support clinicians and patients to make informed treatment decisions, after the Food and Drug Administration released its long-awaited draft rule last week on clinical decision support (CDS) systems. Continue reading
Taken at face value, Right-to-Try (RTT) legislation sounds like a no-brainer, promising to improve access to treatments yet unapproved for marketing by the FDA for people with terminal illnesses. But it’s not that simple, according to Alison Bateman-House, Ph.D., M.P.H., M.A., an ethicist and assistant professor at the New York University School of Medicine.
In fact, many of its basic provisions make it unlikely to deliver on its promise. At a New York City Metro AHCJ Chapter meeting in November, she discussed reasons for her argument that RTT will only serve to limit, rather than expand, access to potentially life-saving treatments. Continue reading
If a new drug appears to show remarkable success in curing patients with a specific, aggressive cancer type that has few or no other effective treatments, there can be a compelling reason to get it on the market as soon as possible.
However, evidence requirements for drugs to receive accelerated FDA approval often rely on surrogate endpoints. That’s particularly true for conditions such as cancer where the ideal primary endpoint — survival — isn’t possible to assess in a short period. Continue reading
Medical devices — and the unrecognized or undisclosed risks some of them have — have been in the news quite a bit over the past few years, especially in the area of women’s health. The death of physician and activist Amy Reed last spring (and the push back she experienced from her advocacy) again drew attention to the dangers of power morcellation during gynecologic laparoscopies. Power morcellation during surgery has been used for two decades, but the research showing that they risk spreading an undetected cancer took much longer to appear, and controversy continues over the technique. Continue reading
Last week’s blog post by Food and Drug Administration Commissioner Scott Gottlieb, M.D., is providing digital health innovators with a new roadmap to navigate pre- and post-market federal oversight of their products.
The topline for journalists is that in the coming months, the FDA will publish new guidance on digital health products and launch programs to monitor the industry, according to the blog post. Key timeframes and details, culled from Gottlieb’s post: Continue reading