As of 6 December, sponsors may opt to use the Food and Drug Administration’s electronic Submission Template And Resource (eSTAR) template for certain premarket approval applications, including original PMAs, PMA panel track supplements, PMA real-time supplements, and PMA 180-day supplements.
eSTAR Now Open For PMA Submissions
The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.
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