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...
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.
Premarketing trials that enroll more diverse patient populations and include targeted CV endpoint collection over longer periods of time could be sufficient to allow new type 2 diabetes drugs to reach market without need for a dedicated safety study, advisory committee members say, urging FDA to move away from current two-step approach to cardiovascular risk assessments.