Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda
US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
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US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
Keeping Track: Novartis Scores Big Ahead Of US Memorial Day With Approvals For Gene Therapy Zolgensma, Oncologic Piqray
The latest drug development news and highlights from our US FDA Performance Tracker.
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.