Duration of Follow Up for New Molecular Entities Approved in 2010, 2012, and 2013

Basic Details
Date Posted
Friday, April 16, 2021
Status
Complete
Medical Product
new molecular entities (NMEs)
Description

In this report we described baseline characteristics and the 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).

Additional Details
FDA Center
CDER
Time Period
January 1, 2010 - January 31, 2019; January 1, 2012 - January 31, 2019; January 1, 2013 - January 31, 2019
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)