Two mouths, if not one voice

Starting next year, companies filing an IND, NDA, BLA or MAA will be able to apply for parallel scientific advice from both FDA and EMEA as a result of the recently disclosed cooperation agreement between the two agencies. But there may be less there than meets the eye, as companies still may end up having to follow two different regulatory pathways.

According to a joint statement by the agencies, the goal of the agreement is "to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies." ...