AmCham meets with FDA

Last week, AmCham Denmark engaged in a roundtable discussion with FDA representatives at the U.S. Embassy, moderated by Stephen Brugger. The session focused on the secondary use of health data for regulatory submissions and drug approvals.

Participants were presented with various FDA guidance documents on Real-World Evidence and the integration of AI in drug development, showcasing the FDA’s innovation-friendly approach to the use of data in submissions and drug approval. AmCham believes that Denmark, along with the broader European community, could greatly benefit from adopting similar practices. In terms of data, we have some excellent tools, but we need to use them properly.

In addition to the U.S. Embassy, several important public organizations in Denmark also participated in the discussion: Confederation of Danish Industry, Danish Chamber of Commerce, Health Tech Hub Copenhagen, Danish BioTech, LIF – Danish Pharmaceutical Industry Association and Danish Medtech Industry Association.

Thank you to Katherine Serrano, Tala Fakhouri, and the rest of the FDA delegation for a great session. And thank you to the U.S. Embassy for hosting this very fruitful discussion.