The FDA now allows many new drugs to be approved based on just one clinical trial, abandoning its long-standing requirement of two studies for most approvals. This change reflects evolving scientific understanding but raises concerns about reduced evidentiary standards.
Since the 1960s, the FDA typically required two well-controlled trials to confirm safety and efficacy. However, since the 1990s, exceptions for rare diseases and terminal conditions have increased, with 60% of recent novel drugs approved via single trials.
Proponents argue modern biology justifies fewer trials, while critics warn that relying on single studies leaves patients unsure of real-world benefits. Experts like Dr. Reshma Ramachandran question whether this lowers standards rather than improving them.
The FDA plans to offset risks by enhancing post-approval monitoring and retaining authority to demand additional studies if needed. However, skeptics doubt whether this will adequately protect patients from insufficiently tested drugs.
The policy aims to accelerate drug development and reduce costs, but its long-term impact remains uncertain. The effectiveness of postmarket oversight will determine whether faster approvals compromise patient safety.
The U.S. Food and Drug Administration (FDA) will now approve many new drugs based on a single clinical trial—a major departure from its long-standing requirement of two studies for most approvals.
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