EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that “deserve special attention, irrespective of statistical criteria used to prioritize safety reviews,” and contribute to the agencys day-to-day pharmacovigilance activities.
Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
“MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices. This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.”
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