Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 22 Jun 2019)

 

Research article
Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation. As FDA increasingly adopts a life…
Authors: Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva, Jennifer E. Miller and Joseph S. Ross
Citation: BMC Medicine 2019 17:117
Published on: 17 June 2019