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Endpoints News
Original article

Pharma industry asks FDA for more details on when one trial is enough

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Summary

Pharmaceutical companies and industry groups are requesting the FDA provide additional details and examples regarding approval pathways using a single pivotal trial plus confirmatory evidence for new drug applications.

Importance:4/10
Sentiment:
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FDA guidancesingle pivotal trialregulatory affairsdrug approval pathway

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Published by Endpoints News on September 25, 2026 4:51 PM

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