Open AccessEvaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals
Author(s) -
Andreas Schick,
Kathleen L. Miller,
Michael Lanthier,
Gerald J. Dal Pan,
Clark Nardinelli
Publication year - 2017
Publication title -
drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.377
H-Index - 124
eISSN - 1179-1942
pISSN - 0114-5916
DOI - 10.1007/s40264-017-0526-1
Subject(s) - medicine , marketing , food and drug administration , clinical trial , warning system , drug , environmental health , pharmacology , business , pathology , engineering , aerospace engineering
An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions.