The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible ...
The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...
FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...
Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...
In recent months, pharmaceutical industry stakeholders and the U.S. Food and Drug Administration (FDA) began formal negotiations on fee levels ...
Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. We are on a bureaucratic trajectory where American leadership in ...
A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...
Recently, VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs, announced that it has received the written meeting ...
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