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    FDA’s Woodcock to Congress: Pass the GDUFA and BsUFA Reauthorizations

    Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, was in the hot seat on Thursday taking questions from the House Energy & Commerce Committee and urging the representatives to pass re-authorizations of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA). While stressing the successes of the first GDUFA, Woodcock told the committee that this next iteration will provide more fundi...
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    EMA Fees to Rise Beginning on 1 April

    Beginning on 1 April 2017, the fees collected by the European Medicines Agency (EMA) from applicants and market authorization holders will increase by 1.2%, in line with the inflation rate in the EU for 2016. According to EMA, the European Commission is working to adopt a regulation to adjust the fees . EMA says it will publish complete details on the fees in late March, after the regulation is adopted. "Members felt that matters relating to the structure and level of ...
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    MHRA Looks to Increase Medical Device Fees

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies. While the agency noted some concerns over the increased costs associated with the fees, it said that the "majority of respondents were content with the fee changes proposed." Last April, MHRA released its business plan for 2016-2017, warning of serious financial troubles for ...
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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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    FDA Explains How GDUFA II Will Help Small Businesses

    The US Food and Drug Administration (FDA) on Thursday offered more details on how the second iteration of the Generic Drug User Fee Act (GDUFA), which must be approved by Congress and President Donald Trump by the end of September 2017, will improve upon the first. One of the biggest proposed changes between the two programs is the creation of a new user fee structure, which was also outlined in the performance goals letter released in October. Gisa Perez, FDA generi...
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    BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump

    The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration. Speaking at the FDA/CMS Summit in Washington, DC last week, Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization (BIO), said she's concerned that the user fee agreements, which were negotiated under the Obama Administration, will be reviewed by a new Congress and new administration, each of which mi...
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    Lead MDUFA Negotiator Details Changes in MDUFA IV Financing

    The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday. Last week, FDA released its draft recommendations for changes to its user fee program for medical devices which would allow the agency to collect roughly $999.5 million— an increase of $320 million over the previous five-yea...
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    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...
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    BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

    A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...
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    NICE to Charge up to £282,000 for Each New Drug Assessment

    The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year. News of the new fees stirred controversy in London’s Sunday Times , and a NICE spokesman emailed Focus on Monday with NICE Chief Executive Sir Andrew Dillon’s response to that story on the fees for technology appraisal and guidance: “Charging pharmaceutica...
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    CDSCO Advances Draft Medical Device Rules, Outlines Fees

    India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders. In June, India announced it was abandoning its plan to amend the Drugs and Cosmetics Act of 1940 in favor of developing new, separate legislation for the regulation of drugs and medical devices. Shortly afterwards, CDSCO released preliminary draft rules est...
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    PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals

    More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a  46-page document  outlining how the agency ...