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Medical Device User Fee Program (MDUFA IV) CDRH

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Womble Bond Dickinson

FDA Suspends Review for Non-COVID-19 In Vitro Diagnostics (IVD) Submissions and Expects Review Delays in Non-IVD Products

Womble Bond Dickinson on

A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing...more

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