Sheila Burke

Sheila Burke

Baker Donelson

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House Advances Bipartisan FDA User Fee Agreements; Senate Faces Narrow Timeline to Act

On July 12, the House passed a five-year reauthorization of four different user fee agreements that account for over a quarter of the Food and Drug Administration's (FDA) overall funding. The legislation, titled "The Food and...more

8/1/2017  /  Biosimilars , BsUFA , FDA Reauthorization Act , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , Prescription Drugs , User Fees

Congressional Committees Advance Bipartisan FDA User Fee Agreements

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

6/23/2017  /  BsUFA , FDA Reauthorization Act , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , Prescription Drugs , Proposed Legislation , User Fees
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