Third-party comprehensive, standards-based 510(k) review program planned by FDA.
This article was originally published in The Gray Sheet
Executive SummaryTHIRD-PARTY COMPREHENSIVE, STANDARDS-BASED 510(K) REVIEW to support FDA substantial equivalence decisions is being pursued by the agency in its development of a third-party review pilot program. As recommended by some industry representatives at a June 19 workshop in Rockville, Maryland, this approach would give third parties a significant role in reviewing 510(k)s and would bring product evaluations more in line with other countries' standards-based premarket review systems.
You may also be interested in...
The Italian firm has some talking to do with the US FDA before it can unblind Phase III data on sarizotan, its Rett syndrome therapy which could be "potentially transformative" for Newron.
No device-related warning letters were released by the US FDA the week of 10 December.
Immuno-oncology development trends are revealed through an analysis of deals between cancer drug developers over the past five years.