FDAMA 114: Improving the Exchange of Pharmacoeconomic Data - Proceedings from the AMCP Partnership Forum

Topic(s):

Pre-Approval Information Exchange , Managed Care Practice Issues

Webinar Recorded on July 20, 2016

Provisions passed under Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA Section 114) established an evidentiary standard for promotional dissemination of health care economic data. However, neither regulations nor guidance in this area have been promulgated by the FDA. AMCP convened a Partnership Forum for stakeholders to discuss clarification and possible expansion of FDAMA Section 114 in March 2016 to obtain consensus recommendations on how information related to this statute should be disseminated. Join AMCP to learn about the recommendations that resulted from the Partnership Forum and AMCP’s efforts to improve the exchange of pharmacoeconomic information.

View the Proceedings from this Partnership Forum