Will Zelnorm Tip The Scales To Increased Drug Safety Oversight Thru PDUFA?
Novartis' suspension of marketing of Zelnorm could add momentum to efforts to attach drug safety reform language to the Prescription Drug User Fee Act reauthorization legislation
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Novartis is emphasizing that the removal of Zelnorm from the market is a suspension rather than a withdrawal
An expansion of FDA's drug safety authorities as envisioned by legislation from Sens. Ted Kennedy, D-Mass., and Michael Enzi, R-Wyo., would require a renegotiation of user fees with industry, Commissioner Andrew von Eschenbach said
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter