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GDUFA

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

BakerHostetler

FDA and Pharmacy Weekly Digest - November 2019 #1

BakerHostetler on

Food/Dietary Supplements - FDA, EPA and USDA Team Up to Reduce Food Waste – The agencies announced a “partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - December 2018 #2

BakerHostetler on

Food/Dietary Supplements - FDA Issues Avocado and Hot Pepper Sampling Reports – The Food & Drug Administration (FDA) has made available two reports related to the sampling of avocados and hot peppers for the presence of...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

Arnall Golden Gregory LLP

AGG Food and Drug Newsletter - November 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...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

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

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

Knobbe Martens

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

Knobbe Martens on

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

Saul Ewing Arnstein & Lehr LLP

House Passes FDA Reauthorization Act; Would Reauthorize Key User Fee Programs and Lengthen Medical Device Malfunction Reporting...

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more

Mintz - Health Care Viewpoints

FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As...more

Baker Donelson

Washington, D.C. Update – June 2017

Baker Donelson on

Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...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

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

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

Mintz - Health Care Viewpoints

Let the 2017 “UFA” Games Begin!

In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series...more

Mintz - ML Strategies

Health Care Update - February 2016 #2

Mintz - ML Strategies on

Martin Shkreli Not the Big Story on the Hill Last Week - Congress’s complex relationship with prescription drugs was on display last week in the House of Representatives. In the House Committee on Oversight and...more

McGuireWoods LLP

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends – Part Two of Two

McGuireWoods LLP on

Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) provided the agency’s new...more

McGuireWoods LLP

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends: Part One of Two

McGuireWoods LLP on

On February 9-11, 2015, a record 765 attendees descended on Miami Beach for the Generic Pharmaceutical Association (GPhA’s) Annual Meeting. Craig Wheeler, President, Momenta Pharmaceuticals, Inc. delivered the welcoming...more

Robins Kaplan LLP

Patent Litigation and Generic Drug Companies: How to Avoid Becoming an “Exceptional Case”

Robins Kaplan LLP on

2013 brought generic drug companies increased financial and legal hurdles when it came to marketing their products in the U.S. First, substantial new GDUFA “user fees” got levied on generics for access to the FDA. Then, the...more

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Privacy Officer
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10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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