Tag Archives: fda

Draft guidance signals FDA seeks to foster innovation in digital health sector

Rebecca Vesely

About Rebecca Vesely

Rebecca Vesely is AHCJ’s topic leader on health information technology and a freelance writer. She has written about health IT since the late 1990s for a variety of publications.

The FDA’s new guidance on digital health paves way for more tools that aim to support physicians and patients.

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

Medical ethicist discusses Right-to-Try legislation

Sibyl Wilmont

About Sibyl Wilmont

Sibyl Wilmont is a second-career registered nurse and clinical researcher with more than 25 years of experience in health care journalism, patient advocacy, pharmaceutical/biotech PR, and academic medical communications.

Photo: Marko Javorac via Flickr

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

How often do drugs obtaining accelerated approval fulfill their potential?

Tara Haelle

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ’s medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Image: Seattle Genetics

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

Study suggests FDA medical device approvals ripe for investigative dives

Tara Haelle

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ’s medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Photo: A.M.D. via Flickr

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

FDA moves on digital health innovation

Rebecca Vesely

About Rebecca Vesely

Rebecca Vesely is AHCJ’s topic leader on health information technology and a freelance writer. She has written about health IT since the late 1990s for a variety of publications.

Photo by Tim Gee via Flickr

Photo by Tim Gee via Flickr

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