Last week, the FDA revised its policy for new drug applications, reducing the requirement from two pivotal trials to one, although experts characterize this as more of an evolution than a revolution in regulatory practice. This change primarily impacts therapeutic areas like neuropsychiatry and metabolic diseases, which have not typically been eligible for one-trial approvals. Despite this shift, many believe that the FDA will still prefer two trials for common diseases, and lingering concerns about regulatory clarity remain prevalent. Experts suggest that until there is more consistency in FDA guidelines, companies may still be better off planning for two trials to mitigate risks associated with potential reversals in regulatory decisions.
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Link to original article source: https://www.biospace.com/fda/fdas-one-trial-policy-not-a-revolution-but-a-potentially-risky-evolution
