FDA defines 510(k) fee schedule:
This article was originally published in Clinica
Executive Summary
Hoping to clear up potential confusion, the US FDA says that with only limited exceptions all 510(k)s submitted for FDA review in fiscal year 2003 are subject to a standard fee of $2,187 for 2004 which begins next October, the agency said.
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Global Pharma Guidance Tracker – March 2024
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