Sean Feely

Akin Gump Strauss Hauer & Feld LLP

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FDA User Fee Reauthorization Legislation Continues to Simmer in Congress: What’s at Stake and What it Means for September

Update on UFA Reauthorization Legislation - As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more

8/15/2022 / BsUFA , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , User Fees

FDA User Fee Reauthorization Gains Momentum with Senate HELP Committee Approval

There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more

6/27/2022 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HELP , Imports , Medical Devices , Prescription Drugs , User Fees

Senate HELP Committee Unveils Draft FDA User Fee Reauthorization Legislation, with Major Reforms to In Vitro Diagnostics,...

On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more

5/24/2022 / Biologics , Biosimilars , Food and Drug Administration (FDA) , GDUFA , Generic Drugs , Medical Devices , PDUFA , Prescription Drugs , User Fees

FDA Preparedness Reforms Come into Focus as the PREVENT Pandemics Act Advances in the Senate HELP Committee

Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more

4/20/2022 / Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , HELP , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Supply Chain

Five Health Care Areas Worth Watching in 2022

With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more

2/4/2022 / Biosimilars , BsUFA , Food and Drug Administration (FDA) , GDUFA , Medical Devices , PDUFA , Prescription Drugs , User Fees

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