• Regulatory NewsRegulatory News

    MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA

    The US Food and Drug Administration (FDA) on Tuesday proposed increasing user fees for medical device manufacturers by more than $320 million over the next five years, according to a draft proposal for MDUFA IV. The new funding will enable FDA to implement a number of proposed enhancements, with additional funding (amounts will also be adjusted for inflation each year) to be phased in over each fiscal year (FY) as follows: $47,419,400 for FY 2018 $54,849,400 for FY...
  • Regulatory NewsRegulatory News

    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
  • Regulatory NewsRegulatory News

    FDA Unveils User Fee Rates for FY 2017

    In the late 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, but for the US Food and Drug Administration (FDA) itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees fr...
  • Regulatory NewsRegulatory News

    Medical Device Companies to See Slight Discount in FDA User Fees in 2017

    Medical device companies will see a modest decrease in application fees for FY 2017 when compared to 2016, according to new fee rates released Thursday by the US Food and Drug Administration (FDA). The 2017 standard fee for a premarket application, premarket report and efficacy supplement (in effect from 1 October 2016 to 30 September 2017) will be $234,495, which is $26,893 less than FY 2016’s fees . Panel-track supplement fees, however, will reach their lowe...
  • Regulatory NewsRegulatory News

    MDUFA IV: Negotiations Step Forward, But Gaps Remain

    The medical device industry is calling for the US Food and Drug Administration (FDA) to add 91 new employees as part of the latest talks over the next version of the Medical Device User Fee Act (MDUFA) , though industry also says it needs more information on several recent FDA proposals. FDA, meanwhile, says industry's proposal, while a step in the right direction, won't add the staff necessary for the agency to meet its performance goals and does not help with several ...
  • Regulatory NewsRegulatory News

    Pharma Companies: FDA Wants New Info for FY2017 User Fees

    The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year. The reminder, which comes in the form of a "Dear Colleague" letter sent to drugmakers earlier this month, instructs companies to complete two attachments to inform the agency of any of a company's products and establishments that are subject to user fees. Under the Prescription...
  • Regulatory NewsRegulatory News

    FDA Outlines Medical Device Real-World Evidence User Fee Proposal

    Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE). The RWE proposal is part of FDA’s counter proposal for the reauthorization of MDUFA, which was presented to industry on 4 March, and would cost $329 million above the cost of MDUFA III. In a meeting on 25 April (the meeting ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    MDUFA IV Negotiations: FDA, Industry Propose New Performance Goals

    At the November meeting on the fourth iteration of the Medical Device User Fee Act (MDUFA IV), the US Food and Drug Administration (FDA) and industry representatives both unveiled new performance targets for de novo submissions, pre-submissions and third-party 510(k) reviews. The MDUFA IV proposal package, which would take effect in 2017, includes the goals of maintaining the MDUFA III FDA performance targets for 510(k) and premarket approval (PMA) submissions, though ...
  • Regulatory NewsRegulatory News

    FDA, Stakeholders Reveal Top Priorities for MDUFA IV Reauthorization

    As the US Food and Drug Administration (FDA) and industry look to deliver recommendations to Congress on the reauthorization of the Medical Device User Fee Amendments (MDUFA) by January 2017, both sides agreed to limit their focus to three top priorities for future stakeholder meetings. The topics nominated in late October as the top priorities include how to incorporate patient perspectives into FDA reviews, how postmarket and premarket device evidence will be better ut...
  • Regulatory NewsRegulatory News

    FDA, Industry See Progress in MDUFA IV Negotiations

    At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction. The negotiations center on the use of a system whereby medical device companies pay fees to FDA to register their establishments and list their devices with the agency. The fees help FDA increase the ef...
  • Regulatory NewsRegulatory News

    FDA Unveils User Fee Rates for FY2016

    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, but for FDA itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a more timely manner. The solution FDA proposed was to collect one-time fees from the companies it regulates...