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The FDA plans to reduce the number of required pivotal trials in Phase 3 clinical studies from two to one, aiming to streamline drug development. While this may benefit smaller biotech companies, the impact will vary by disease, as some conditions may still necessitate more trials to ensure safety and efficacy.
- FDA is shifting the default Phase 3 requirement from two pivotal trials to one, potentially cutting years and money off the $2.6 billion, 10-15 year drug development process.
- The impact will be uneven: urgent diseases like ALS could benefit from faster single-trial approval, while high-placebo-response conditions like pain may struggle to prove efficacy with just one study.
- Smaller biotechs with limited funding but multiple drugs in development stand to gain the most from reduced trial requirements.
- FDA plans to offset reduced pre-approval testing with continued postmarket surveillance and new tools like AI and real-world data to maintain safety and precision.
The FDA plans to allow drug approvals based on a single clinical trial instead of the traditional two. Commissioner Marty Makary stated that this change aims to streamline the approval process while maintaining safety and efficacy standards. Some exceptions will still apply, where two trials may be required.
- FDA will now generally accept a single clinical trial for drug approval instead of the traditional two
- Two trials will still be required in certain (unspecified) cases
- Makary argues a well-designed, controlled single trial can match the statistical power of two trials
- Many drugmakers were already submitting only one pivotal trial, so the policy formalizes existing practice