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    Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess

    Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week. McConnell called to renew the user fee programs as they are “critical to speeding up the drug approval process, and that’s important for everyone frustrated by the time and cost of bringing lifesaving drugs to market. Without it, ...
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    House Passes Bill to Reauthorize FDA User Fee Programs

    In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022. Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name dr...
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    House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess

    The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off. The bipartisan House user fee bill , which sailed through the Energy & Commerce committee unanimously last month, has be...
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    HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees

    Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations. Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee pro...
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    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...
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    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...
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    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...
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    PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals

    The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier. The comments were made in response to FDA's assessment of its program for enhanced review transparency and communication for new molecular entity new drug applications (NME NDAs) and or...
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    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...
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    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...
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    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...
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    FDA to Discuss Autism and Available Treatments in May

    An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches. Background As part of commitments tied to the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under Title I of the Food and Drug Administration Safety and Innovation Act , FDA has selected autism as the focus of a public meeting on 4 May 2017, fr...