Nathan Downing

Nathan Downing

Gardner Law

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The Value of MDUFA

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

7/24/2025  /  Compliance , Drug Pricing , FDA Approval , Fees , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Research , Public Health , Regulatory Requirements
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