Advocacy Grand Rounds: Beneficial to Whom? A Review of Makena and the FDA’s Accelerated Approval Process

The FDA-approved pregnancy drug Makena was recently under fire due to its lack of proven benefit. Join DFA’s FDA Task Force for this session, which will uncover flaws in the current accelerated approval process that allowed Makena to be authorized by the FDA, as well as considerations as the drug is under review by the FDA. 

Session takeaways/promo points:

1. Give an overview of the accelerated approval and its drawbacks
2. Give background on pregnancy drug Makena & recent FDA reviews of its effectiveness
3. Learn about the importance of clinical trial diversity

Come join us on this important topic as we will hear from Dr. Ealena Callender and Dr. Adam Urato. We will have Reuben Mathew moderating this informative session.