• Feature ArticlesFeature Articles

    FDA User Fee Programs

    This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies. 1-3 Introduction Prior to the passing of the Prescription Drug User Fee Act ( PDUFA ), FDA experienced backlogs in its drug approval proces...
  • Regulatory NewsRegulatory News

    User Fee Reauthorization Bill Amended Ahead of Wednesday Vote

    Ahead of Wednesday’s Senate health committee vote on the five-year reauthorizations of the US Food and Drug Administration (FDA) user fee agreements, the committee has released an updated version of the legislation that includes several medical device bills discussed on the House side. The so-called manager’s amendment of the bill features the same drug, medical device, biosimilar and generic drug user fee agreements crafted over the past two years, as well as ne...
  • Regulatory NewsRegulatory News

    Senate Committee to Vote on FDA User Fee Reauthorizations

    Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements. The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices. The proposed reauthorizations, grouped ...
  • Regulatory NewsRegulatory News

    Government Spending Bill Would Boost FDA Funds by Almost $40M

    The US House and Senate appropriations committees on Monday released government spending bills through the end of this fiscal year, offering the US Food and Drug Administration (FDA) a boost in discretionary spending and user fee revenues. In total, the agreement on spending through 30 September 2017 contains $153.4 billion in discretionary and mandatory funding, which is $16.3 billion below President Donald Trump’s FY2017 budget request and $12.5 billion above the FY20...
  • Regulatory NewsRegulatory News

    House to Consider MDUFA Add-Ons

    With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package. On Tuesday, the E&C subcommittee will discuss four bills that look to make hearing aids more accessible to patients over-the-counter , overhaul FDA's inspection program for device establishments , ...
  • Feature ArticlesFeature Articles

    The Prescription Drug User Fee Act (PDUFA): A Primer

    This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process. Introduction: Benefits Offered by PDUFA When planning a New Drug Application (NDA) or other type of marketing application, regulatory professionals must consider many things. These considerations include: when the data will com...
  • Regulatory NewsRegulatory News

    Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees

    With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022. Forged via negotiations between FDA and the various industries dating back to 2015, and racing to beat a September deadline, the bills sequentially increase the amount of user fees FDA can assess for r...
  • Regulatory NewsRegulatory News

    Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

    Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts. Those layoffs, if Congress and President Donald Trump fail to act before 1 August or Congress’ summer recess, would significantly curtail new medical product...
  • Regulatory NewsRegulatory News

    Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

    Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act ( PDUFA VI). And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) detailed how the agency's ability to...
  • Regulatory NewsRegulatory News

    CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee

    The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals. All three officials highlighted the past successes of the user fee programs, and overall, it did not seem as though user fee goals letters would be reworked or that further negotiations would be needed before the b...
  • Regulatory NewsRegulatory News

    Trump FY 2018 Budget Blueprint: Hike in FDA User Fees?

    President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA). While the blueprint offers little detail on what such cuts would actually mean for the agency and pharmaceutical, biotech and medical device industries, the plan says it would recalibrate FDA medical product user fees “to over $2 billion in 2018, approximate...
  • Regulatory NewsRegulatory News

    CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year." On the informatics front, Woodcock said that last summer, the executive committee of the FDA had a retreat and "the number one item there was improving and really implementing Informatics Process Management and so forth across the w...