FDA Slows Down Accelerated Approval Pathway Products Program
With drugs taking longer to hit the market, will biopharma’s approval count be affected?
According to data taken by Evaluate Vantage, only 12 percent of novel drugs arrived on the market last year via the FDA’s accelerated approval pathway program. As a result of a new restriction, a further decline of approved medicines can be expected by the end of 2023.
Heavy use of this feature in recent years provided a massive boost to the FDA’s approval count, peaking at 58 percent in 2021. Speedy approval in niche and underserved settings can of course benefit patients in the longer term, but the need to establish both the risks and benefits of these agents, as expeditiously as possible, remains.
Reference
The Waxing and Waning of the Speedy Approval. May 15, 2023 / Evaluate
Navigating Distrust: Pharma in the Age of Social Media
February 18th 2025Ian Baer, Founder and CEO of Sooth, discusses how the growing distrust in social media will impact industry marketing strategies and the relationships between pharmaceutical companies and the patients they aim to serve. He also explains dark social, how to combat misinformation, closing the trust gap, and more.
