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Duration of Follow Up for New Molecular Entities Approved in 2014 and 2015

Basic Details
Date Posted
Status
Complete
Medical Product
new molecular entities (NMEs)
Description

The purpose of this analysis was to describe baseline characteristics and the duration of follow-up time among new users of 39 new molecular entities (NMEs) approved in 2014 and 45 NMEs approved in 2015 by the U.S. Food and Drug Administration in the Sentinel Distributed Database (SDD). We distributed this request to 17 Data Partners on May 10, 2019.

This analysis contains two reports: 

  • Report 1: This report contains data on users of NMEs approved in 2014. The study period was from January 1, 2014 to August 31, 2018.
  • Report 2: This report contains data on users of NMEs approved in 2015. The study period was from January 1, 2014 to August 31, 2018.
Deliverables (2)
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2014, Report 1 Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2015, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2014 - August 31, 2018
Analysis Type
Descriptive
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Duration of Follow Up for New Molecular Entities Approved in 2019: A Descriptive Analysis
Duration of Follow Up for New Molecular Entities Approved in 2018: A Descriptive Analysis
Duration of Follow Up for New Molecular Entities Approved in 2017: An Updated Descriptive Analysis
Duration of Follow Up for New Molecular Entities Approved in 2017: A Descriptive Analysis
Duration of Follow Up for New Molecular Entities Approved in 2016
Duration of Follow Up for New Molecular Entities Approved in 2010, 2012, and 2013
Duration of Follow Up for New Molecular Entities Approved in 2011
Duration of Follow Up for New Molecular Entities Approved in 2008 and 2009
Duration of Follow Up for New Molecular Entities Approved in 2005, 2006, and 2007
Sentinel Drug Study: New Molecular Entities (NMEs) & Utilization Characterization