Michael Mezher of Regulatory Affairs Professionals Society (RAPS), recently published an article about the European Medicines Agency (EMA) and its Adaptive Pathways Pilot. The Adaptive Pathways Pilot helps speed up patient access to medicines otherwise not available. For those companies applying to the Adaptive Pathways Pilot, the EMA is finding it necessary to communicate more specific guidelines. Specifically, applicant drug development plans must meet three criteria outlined in Mezher’s article.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.