What do the next 5 years look like for the FDA? Congress is expected to reauthorize all of the user fee agreements between the FDA and biopharma companies this fall, setting in motion new timelines and centers of focus for the agency. What can biopharma companies expect, and what might Congress stuff into these agreements at the last minute? And what happens if Congress doesn’t act in time?
A one-on-one conversation with Harvard Medical School’s Aaron Seth Kesselheim discussing topics at the forefront of the industry.
As Congress looks to shift the landscape around accelerated approvals, the FDA will need to decide how to enable the changes Congress puts down on paper. Our panel of experts will discuss the newly proposed changes and how they’ll impact R&D, how the FDA will interpret what Congress has changed, and who (companies or patients) stands to benefit the most.
