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eSTAR Now Open For PMA Submissions

 
• By Brian Bossetta

The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.

Electronic Submissions
• Source: Shutterstock

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.

The FDA launched eSTAR in 2020 after a voluntary pilot program to improve how the agency processed product reviews. (Also...

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