FDA Schedules Webinar to Discuss FDA-EMA Parallel Scientific Advice Program

The FDA has scheduled a March 16 webinar to report on the status of its FDA-EMA Parallel Scientific Advice Program.

The webinar is designed to help regulatory affairs professionals and researchers working on global product development programs as well as foreign regulators gain a general understanding of the program, including how to submit a Parallel Scientific Advice (PSA) request, and the expected procedure timeline and outcomes.

The PSA program, shared by the European Medicines Agency (EMA) and the FDA, enables the regulators to engage in scientific discourse with sponsors during the development phase of new medicinal products.