A recent webinar on the FDA-EMA parallel scientific advice (PSA) program for complex generics aimed to increase sponsor interest in the program, but also included some blunt acknowledgements about why it has so far not drawn many participants.
EMA’s senior scientific specialist of clinical pharmacology Kevin Blake began his session – titled “EMA and International Engagement for Generics Development” – by explaining that the pilot aspect of the scheme relates to processes in place from both regulators, such as timelines or various steps involved