CERTs Risk Management Agenda Includes Tikosyn Study, Workshops
Executive Summary
The initial results from a CERT study of the risk management program for Pfizer's anti-arrhythmia drug Tikosyn (dofetilide) may indicate some practical limits to well-designed monitoring plans, Office of Postmarketing Drug Risk Assessment Director Peter Honig, MD, suggested Nov. 5
You may also be interested in...
QT Guidance Reducing Number Of Drugs Leaving Early Development, Firms Say
Stricter guidelines on QT prolongation are forcing manufacturers to drop compounds earlier in the development process, participants said during an FDA/Duke Cardiac Safety and Critical Path Initiative Think Tank meeting Oct. 11
QT Guidance Reducing Number Of Drugs Leaving Early Development, Firms Say
Stricter guidelines on QT prolongation are forcing manufacturers to drop compounds earlier in the development process, participants said during an FDA/Duke Cardiac Safety and Critical Path Initiative Think Tank meeting Oct. 11
Drug Risk Assessment Needs IoM Report To Synthesize Research – CERTs
The Institute of Medicine should study the current state of pharmaceutical risk assessment and recommend methodological and research improvements, participants in a Centers for Education & Research on Therapeutics risk assessment workshop suggested