FDA to Drop Two-Study Requirement for New Drug Approvals

Back to news list

Source: MedPage Today

Original: https://www.medpagetoday.com/publichealthpolicy/clinicaltrials/119944...

Published: Thu, 19 Feb 2026 10:20:17 -0500

The FDA plans to drop a long-standing standard that required two rigorous studies to approve new drugs. This change comes from Trump administration officials. The aim is to speed up the availability of certain medical products. Until now, the requirement of two studies has been the standard for obtaining approval. The change represents the latest initiative to speed up drug approvals. With this step, the FDA is changing its procedure in the field of registration of new drugs.