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  • Regulatory NewsRegulatory News

    House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017

    The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA). That level of appropriations, which stands in stark contrast to President Donald Trump’s call to eliminate appropriations for FDA and run the agency entirely on industry user fees, would continue FDA’s budget authority (BA) appropriations at the...
  • Regulatory NewsRegulatory News

    Trump’s 2018 Budget Seeks Last-Minute Renegotiation of FDA User Fee Deals

    President Donald Trump's FY 2018 budget proposal for the US Food and Drug Administration (FDA), leaked late Monday, seeks a last-minute renegotiation of user fee deals forged over the last two years to make up for about a 30% decrease in the agency’s budget. The call for more than $1 billion in new user fees to replace appropriations comes as both the House and Senate have advanced their versions of the user fees reauthorization legislation with the previously negoti...
  • Regulatory NewsRegulatory News

    GPhA: Congress Needs to Work With FDA to Increase Generic Competition

    The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday. ANDA Backlog First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should...
  • Regulatory NewsRegulatory News

    FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015

    The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs. The current FY 2014 user fees are also displayed, as are fees from FY 2013, when most programs were overhauled under the Food and Drug Administration Safety and Innovation Act (FDASIA) . Thi...
  • FDA to Generic Drug Industry: User Fee Program Leading to Significant Improvements

    Perhaps no industry regulated by the US Food and Drug Administration (FDA) is undergoing as big a change in the way it is regulated right now as the generic drug industry. Background Under the terms of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the generic drug industry must now contribute to FDA's operational budget through user fees. Those fees are paid every time a company submits an abbreviated new drug application, a drug master...
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    RAPS Award Winners Reflect on Importance of Regulatory Profession and Giving Back

    Each year, when the recipients of RAPS' prestigious annual awards for outstanding contributions to the regulatory profession take the stage at RAPS' annual Regulatory Convergence conference, they find themselves somewhere unfamiliar to most regulatory professionals-in the spotlight. Annually, RAPS bestows upon a select group of worthy honorees, several awards for exemplary professional leadership, volunteerism, mentoring and advancement of the regulatory profession, whi...
  • Flurry of Year-End Drug Approvals Makes 2012 Best Year for Approvals Since 1997

    The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high. US regulators approved at least seven high-profile and mostly new drug products during the final two weeks of 2012, including: Varzig (varicella zoster immune globulin preparation) - Cangene Corporation : Approved for reducing the severity of chicken pox infections in high-risk individuals. ...
  • FDA's Two-year Approval Record Marks 15-Year Best, Report Finds

    The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims-the best two-year approval record in 15 years. The agency's "Fiscal Year 2012 Innovative Drug Approvals" report notes that FDA has already "used expedited approval authorities and flexibility in advising sponsors on clinical trial design to approve 35 new novel drugs" this past fiscal year (1 October 2011 through 30 Sept...
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    FDA, Industry Outline Impact of PDUFA V at 2012 RAPS

    Renewed every five years, the Prescription Drug User Fee Act (PDUFA)  is one of the single most important and successful pieces of legislation affecting both the US Food and Drug Administration (FDA) and the pharmaceutical and biopharmaceutical industries. The legislation, originally conceived and passed in 1992, operates on a relatively simple principle: in return for industry-paid user fees, FDA is responsible for hiring additional staff with which to review drug...
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    Regulatory Experts Urge Caution With Communications Activities

    The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters. During a panel discussion at 2012 RAPS: The Regulatory Convergence , regu...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...
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    Regulatory Professionals, Top Regulators From Around the World to Converge in Seattle for 2012 RAPS

    In a few weeks, 2012 RAPS: The Regulatory Convergence will bring approximately 70 healthcare regulators and some 2,000 total attendees from around the world to Seattle. The regulatory officials scheduled to speak represent national and international agencies overseeing health products, including 36 speakers from the US Food and Drug Administration (FDA), as well as representatives from agencies in Europe, China, Japan, India, Brazil, Canada and more. The Regulatory Conv...