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Federal Food Drug and Cosmetic Act (FFDCA) GDUFA

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

King & Spalding

Act II: The Senate Unveils Its Draft

King & Spalding on

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

Mintz - Health Care Viewpoints

Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?

Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more

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

Latham & Watkins LLP

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

Latham & Watkins LLP on

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...more

Mintz - Health Care Viewpoints

More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more

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