The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies can rely on existing scientific knowledge to avoid unnecessary tests and speed up the development process, the agency exclusively told Axios.
Why it matters: The move could be seen as an olive branch to the drug industry and the rare disease community in the wake of former commissioner Marty Makary's departure. But it still will all come down to how the guidance is implemented.
A new bid to fix the process for resolving surprise billing disputes may not make a dent in the massive backlog of cases.
Why it matters: Providers and insurers have been sparring over how to settle claims for out-of-network services almost from the moment Congress protected privately insured patients from getting stuck with huge, unexpected costs.
After years of talking to hundreds of CEOs, elected officials, social scientists and ordinary Americans, this is our best take on how things stand in our country right now and a guide to how we got here.
On Tuesday, Jim will outline why he believes CEOs and business leaders are uniquely suited to step up and help fill the trust void in this moment.
We're living through the most disorienting societal moment since World War II. Almost nobody in a position of power is explaining why, or what to do about it.
This is so much bigger than politics. It touches our jobs, our companies, our communities and our realities.
Why it matters: By most objective measures, it's an extraordinary time to be alive. Americans are wealthier, safer and longer-lived than at any earlier point in history. U.S. total wealth has soared. Violent crime sank to a 20-year low and is still falling. Life expectancy just hit 79 years — the highest in American history. The country produces more energy than ever after four straight record years.
A Trump administration proposal to overhaul how research agencies award grants is stoking new fears about political interference in publicly funded medical research.
The big picture: The document tracks with past administration efforts to cut funding, but would establish a standard framework for the whole government.
The administration wants to reduce funding for research it says doesn't support the mission of agencies like National Institutes of Health, including diversity, equity and inclusion initiatives.
