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FDA Tweaks Final Guidance for PMAs and Device BLAs

Posted 12 December 2018 | By Ana Mulero 

FDA Tweaks Final Guidance for PMAs and Device BLAs

The US Food and Drug Administration (FDA) made minor revisions to a 2017 final guidance on Wednesday on user fees and refunds for premarket approval applications and device biologics license applications.
 
The minor revisions to the final guidance, issued in October 2017, merely incorporated information on device biologics license applications from a superseded guidance.
 
Portions of FDA’s previous guidance on assessing user fees were superseded by the “Bundling Multiple Devices or Multiple Indications in a Single Submission” and the “Real-Time Premarket Approval Application (PMA) Supplements” guidance documents, FDA said. The “Assessing User Fees’ guidance is now entirely superseded and will be removed from the FDA website.”
 
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Final Guidance

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