Accelerated Approval Status Disclosure Would Be Mandated By Markey Bill
This article was originally published in The Pink Sheet Daily
Sponsors would be required to inform patients and physicians if a product received accelerated approval under legislation to be introduced by Rep. Ed Markey (D-Mass.). Report by Markey’s office finds that 50% of outstanding postmarketing study requirements have not been started.
You may also be interested in...
Center for Postmarket Drug Evaluation & Research would be able to levy fines starting at $250,000 for failure to complete postmarketing studies on time and for failure to comply with "corrective actions" under the legislation. FDASA would give the independent drug safety office authority over labeling changes and promotional materials.
Gefitinib fails to demonstrate a survival benefit in the Iressa Survival Evaluation in Lung cancer confirmatory trial. AstraZeneca will meet with FDA to determine whether accelerated approval licensure of Iressa will be withdrawn, CEO McKillop says.
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