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.
You may also be interested in...
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.
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.
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.