Single Database Of FDA Actions Could Improve Drug Development, Sanofi Says
Sanofi exec advocates development of comprehensive dataset of US FDA regulatory processes and outcomes to enable sponsors to anticipate agency expectations.
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FDA 'Consistency' Is Industry Watchword For Promoting Effective Drug Development
Pharma companies and associations cite numerous examples of getting inconsistent advice across review divisions, including the number of clinical trials required for rare disease drugs and acceptance of innovative clinical trial designs and novel endpoints.
Genomics Data Should Get More Attention In FDA Drug Review And Labeling, Regeneron Says
Regeneron advocates industry-FDA collaboration to establish regulatory standards for novel applications of genomic data, such as determining whether long-term outcomes studies are needed, and inclusion of the data in product labeling.
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.