Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. In a move that could dramatically reshape the landscape for rare ...

Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway ...

San Diego – The US Food and Drug Administration’s (FDA) top biologics official said the proposed Promising Pathways Act would lower the bar for approving treatments for rare diseases and that the ...

Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England ...

FDA is proposing the PM pathway largely in response to concerns from patient advocates and industry stakeholders that FDA’s existing product approval pathways lack sufficient flexibility for ...

“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...