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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

Akin Gump Strauss Hauer & Feld LLP

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

Akin Gump Strauss Hauer & Feld LLP on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Akin Gump Strauss Hauer & Feld LLP

Five Health Care Areas Worth Watching in 2022

Akin Gump Strauss Hauer & Feld LLP on

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

Mintz - Health Care Viewpoints

FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round

Mintz - Health Care Viewpoints on

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

Arnall Golden Gregory LLP

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

Arnall Golden Gregory LLP on

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and...more

King & Spalding

President Trump Signs FDA User Fee Reauthorization Bill into Law – A Relief for the Medical Device Industry

King & Spalding on

On August 18, 2017, in the nick of time, President Trump signed the FDA User Fee Reauthorization Bill of 2017 (FDARA) (H.R. 2430) into law, bringing a sigh of relief from both FDA and Industry. The law reauthorizes the...more

Akin Gump Strauss Hauer & Feld LLP

Senate Passes Long-Awaited FDA User Fee Package

Akin Gump Strauss Hauer & Feld LLP on

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Baker Donelson

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

Baker Donelson on

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

Baker Donelson

Congressional Committees Advance Bipartisan FDA User Fee Agreements

Baker Donelson on

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

Mintz - Health Care Viewpoints

FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

Mintz - Health Care Viewpoints on

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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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