Category European Medicines Agency

EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…

The EU Digital Application Dataset Integration Project (DADI) project on web-based regulatory application forms

The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears…