Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda
Executive SummaryUS FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
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Keeping Track: Novartis Scores Big Ahead Of US Memorial Day With Approvals For Gene Therapy Zolgensma, Oncologic Piqray
FDA will track RWE submissions under INDs, NDAs or BLAs and wants sponsors to use a simple, uniform format to identify real-world data sources and evidence generated from that data in such filings.