Litcius/Paper detail

The FDA Struggle to Withdraw Makena

Daniel Aaron, I. Glenn Cohen, Eli Y. Adashi

2022JAMA13 citationsDOI

Abstract

This Viewpoint discusses the controversy surrounding the FDA’s efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.

Topics & Concepts

MedicineDrug approvalPharmacologyDrugPreterm Birth and ChorioamnionitisPregnancy and Medication ImpactReproductive Health and Contraception