• 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...
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    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...
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    GOP Sets June Deadline for Completing FDA User Fee Reauthorizations

    Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs. The setting of the deadline, according to a document obtained by Politico, comes as FDA staff and Congressional staff have recently cancelled meetings to work on the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI), the Medical Device User Fee Act (MDUFA IV), the Generic Drug User Fee Act (G...
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    PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

    Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA ) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a 46-page document outlining how the agency will use t...
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    MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal

    Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA). In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees...
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    PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting

    The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA). Background In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, b...
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    FDA Kicks off Reauthorization Process for PDUFA

    The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug products in the US are reviewed. Background PDUFA was first authorized in 1992, and has since been reauthorized four times, most recently in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . As with FDA's other user fee programs, PDUFA is based o...
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    As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder

    In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats. But while the bill received little attention and even less congressional opposition at the time, an outbreak of Ebola in West Africa is now making the bill's passage—and FDA's ...
  • House Meets to Discuss PDUFA, MDUFA User Fees

    • 18 April 2012
    The House Energy and Commerce Committee is meeting 18 April starting at 10:15 AM to discuss various proposed user fee agreements, including the Prescription Drug User Fee Act (PDUFA)  and the  Medical Device User Fee Act (MDUFA)  reauthorization bills on 18 April. The hearing, entitled "US Food and Drug Administration User Fees 2012: How Innovation Helps Patients and Jobs," will be taking place at room 2123 of the Rayburn House Office Building. A webcast...
  • Shuren's Senate Testimony Yields Wealth of Insight

    The US Food and Drug Administration's (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education, Labor and Pensions Committee yesterday (29 March), providing a wealth of information on CDRH, the medical device review process and agency performance. Shuren's testimony also yielded a wealth of other information of interest to regulatory professionals, including: FDA request...
  • UPDATED: FDA Completes Work on Three User Fee Acts, Sends to Congress

    Right on schedule , the US Food and Drug Administration (FDA) today confirmed that it has finished work on three user fee programs that will be sent to the Congress immediately. In a blog posting on the FDA Voice blog, FDA Commissioner Margaret Hamburg called the existing User Fee Acts "highly successful" programs that were responsible for "revolutionizing the drug approval process." Hamburg noted that Department of Health and Human Services Secretary Kathleen Sebe...
  • Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

    The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization,  Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA). The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg ...