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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Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020
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.
Real-World Evidence Should Be Flagged In US Drug And Biologic Applications
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.