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BsUFA

Goodwin

FDA Seeks Input on Biosimilar Product Development Guidance

Goodwin on

​​​​​​​On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of...more

Hogan Lovells

FDA seeks industry input on biosimilar guidance development

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the establishment of a public docket to obtain information and comments to help FDA assess how best to advance the development of new biosimilar biological...more

Goodwin

FDA Accepts Xbrane’s sBLA for LUCENTIS® (Ranibizumab) Biosimilar Candidate

Goodwin on

​​​​​​​ On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS® (ranibizumab) biosimilar...more

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

Goodwin

Biocon and Alvotech Release Statements on FDA Inspections

Goodwin on

​​​​​​​On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. 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

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

Foley & Lardner LLP

What’s Next in Washington? - July Edition

Foley & Lardner LLP on

With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...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

Foley & Lardner LLP

What’s Next in Washington? - June 2022

Foley & Lardner LLP on

Unexpected events last month re-energized two key policy debates. In early May, a leaked draft opinion by Justice Samuel Alito showed that the Supreme Court is poised to overturn Roe v. Wade in its decision of Dobbs v....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

Foley & Lardner LLP

What’s Next in Washington? - May 2022 Edition

Foley & Lardner LLP on

Congress recently returned from its two-week recess with an extensive to-do list. Between now and the August recess, the House will be in session for a total of 32 legislative days, and the Senate will be in for 54...more

Foley & Lardner LLP

What’s Next in Washington? - April 2022

Foley & Lardner LLP on

While Congress has a two-week recess in April, there are many priority items on the agenda this month. Less than two weeks after signing the Fiscal Year (FY) 2022 spending package, President Biden released his budget for FY...more

Goodwin

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Goodwin on

Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee...more

Akin Gump Strauss Hauer & Feld LLP

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

Bergeson & Campbell, P.C.

FDA Requests Comments On Reauthorization Of BsUFA

On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027....more

Mintz - Health Care Viewpoints

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

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

Baker Donelson

Recent FDA Plan to Improve Marketplace for Biosimilars

Baker Donelson on

The Biologics Price and Competition and Innovation Act (BPCI Act) established an abbreviated pathway for biologics, called biosimilars, in 2010. The FDA has committed to encourage the development of biosimilars in a...more

Goodwin

FDA Releases Five-Year Plans for User Fee Programs

Goodwin on

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...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

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

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

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