Details
Description
The purpose of this analysis was to describe the baseline characteristics and duration of follow-up time among new users of 20 new molecular entities (NMEs) approved in 2010, 38 NMEs approved in 2012, and 28 NMEs approved in 2013 by the U.S. Food and Drug Administration in the Sentinel Distributed Database (SDD).We distributed this request to 17 Data Partners on January 31, 2019
This analysis contains three reports:
- Report 1: This report contains data on users of NMEs approved in 2010. The study period was from January 1, 2010 to June 30, 2018.
- Report 2: This report contains data on users of NMEs approved in 2012. The study period was from January 1, 2012 to January 31, 2019.
- Report 3: This report contains data on users of NMEs approved in 2013. The study period was from January 1, 2013 to January 31, 2019.
Deliverables (3)
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2010, Report 1
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2012, Report 2
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2013, Report 3