Posted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA and the EMA shows that the agencies received a total of 37 applications from sponsors of new medicines and accepted 70% of requests.
The program, which launched in 2005, provides a mechanism for sponsors of new medicines to seek concurrent advice from regulators in the US and Europe on scientific issues involved in product development. It is a voluntary program and is triggered by a request from a sponsor.
