Biosimilar User Fee Collections Climb; Application Growth Less Clear
FDA plans to send out 57 invoices for annual biosimilar product development fees in fiscal year 2016, 10 more than were sent last year, but agency remains mum on how many 351(k) submissions it expects.
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Interactive chart of growing 351(k) pipeline shows that while Phase III is dominated by big players, pure-play biosimilar companies are beginning to emerge.
Advisory Committee on Immunization Practices fails to pass an interim recommendation endorsing third dose of vaccine in health care workers and others at risk of occupational or institutional exposure, with panelists raising concern that the target population was overly broad.
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’