Apr 02, 2026
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Mar 31, 2026
Clinical trials take 10-15 years and cost $1-2 billion from discovery to approval, progressing through four phases from safety testing to real-world monitoring. These studies face challenges including high costs, regulatory oversight, and participant recruitment while new technologies are transforming trial design. Illinois faces a shortage of Phase I clinical trial facilities despite local companies conducting over 50 such trials annually.
Feb 19, 2026
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA flu vaccine after initially refusing the application, while separately announcing it will drop its longtime requirement for two clinical studies to approve new drugs.
