In the increasing controversy surrounding FDA’s accelerated approval pathway, it’s far too easy to overlook why this pathway exists in the first place — to define a medicine’s value through its clinical utility, while striking a regulatory balance between quality, speed and value. The key “red thread” behind much of this manufactured controversy is the prioritization of…
BOSTON — Leaning into the symbolism of President John F. Kennedy’s aspirational effort to send a man to the moon, President Biden on Monday sought to give a renewed boost to his own “cancer moonshot” initiative, aimed at cutting the U.S. death toll from the disease in half over the next 25 years. Biden delivered…
President Joe Biden has chosen Renee Wegrzyn, a 45-year-old applied biologist with a background in industry and government, to head his new agency for biomedical innovation, the Advanced Research Projects Agency for Health (ARPA-H). Congress created ARPA-H in March with a starting budget of $1 billion. It aims to bring to biomedical research the kind of innovation…
WASHINGTON — President Biden, sketching out a vision for “bold approaches” to fighting cancer and other diseases, announced on Monday that he had selected Dr. Renee Wegrzyn, a Boston biotech executive with government experience, as the director of a new federal agency aimed at pursuing risky, far-reaching ideas that will drive biomedical innovation. Mr. Biden…
Convergence 2022 is back in person in Phoenix, AZ, with updates from US regulators and health authorities around the globe, career transitions and professional development sessions, and wellness breaks. Members of the RAPS Convergence Planning Committee said they wanted to provide a variety of options for attendees, with content that tackles the regulatory challenges beyond the…
As Congress returns from its annual August recess the familiar September task of reconciling the Federal budget before the end of the fiscal year is at hand. This year, however, during a compressed legislative session, a dire public health risk hangs in jeopardy. It is critical for Congress to complete the five-year reauthorization process of…
Key Points: Clinical trials are crucial to the development of new standards of care for all patients with cancer; to date, however, a minority of patients have had the opportunity to participate in these trials. Several abstracts presented at the 2022 ASCO Annual Meeting highlight the positive effects of increasing inclusiveness and advancing equity in…
Abstract Studies that generate real-world evidence on the effects of medical products through analysis of digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers. Ensuring reproducibility of such findings is fundamental to effective evidence-based decision-making. We reproduce results for 150 studies published in peer-reviewed journals using the same…
The pros and cons of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, various iterations of which have been circulating since 2018, was the topic of a lively panel discussion during last week’s Next Generation Dx Summit in Washington, D.C. Those supporting the legislation, intended to modernize regulatory processes for in vitro diagnostics (IVDs) and laboratory-developed-test (LDTs), point to…
WASHINGTON, Aug. 30, 2022 /PRNewswire/ — LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, convened a team of oncology thought leaders, the United States Food and Drug Administration, the National Cancer Institute, and industry sponsors to develop recommendations for a framework for lung cancer clinical trial eligibility criteria. The eligibility template recommendations, published recently in JAMA Oncology,…
