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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

    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...
  • FDA Publishes 33rd Edition of Orange Book

    • 21 February 2013
    The US Food and Drug Administration (FDA) has released its 33 rd edition of its so-called " Orange Book "-its listing of all approved drug products and their therapeutic equivalence evaluations. Background The book is widely used in the regulatory community for identifying which drug products are substitutable for one another. The book contains all drug products that are approved or have not been withdrawn for reasons of safety or efficacy with the exception of produc...
  • 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...
  • CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

    It's that time of year-the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no exception to this trend, and its Center for Devices and Radiological Health (CDRH) has just published its 2013 Strategic Priorities plan. Calling the plan a continuation and expansion of its efforts to promote "smart regulation," CDRH said it is reorganizing its plan to better ...
  • Budget Passes Senate, Leaving User Fees at 2012 Levels

    Both chambers of Congress have now passed a continuing resolution that would keep the government's-and the US Food and Drug Administration's (FDA)-budget at existing fiscal year 2012 levels, averting a government shutdown but also leaving in limbo several important FDA programs. Legislators scrambled on 21 September to pass a legislative fix for the establishment of fees for generic drug products, but did not establish similar exemptions for prescription drug, medica...
  • Upcoming Medical Device User Fees Unveiled

    • 30 July 2012
    The schedule of fees medical device manufacturers and sponsors will be required to pay under the Medical Device User Fee Act (MDUFA) -part of the recently passed Food and Drug Administration Safety and Innovation Act (FDASIA) -was released on 30 July by US regulators. The fees apply only to the fiscal year between 1 October 2012 and 30 September 2013, after which time an inflation-adjusted set of fees are set to come into effect. The base fee for a premarket applicati...
  • FDA Receives Small Funding Boost In Senate Appropriations Bill

    The US Food and Drug Administration (FDA) could see an addition $24 million in funding under a bill cleared by the Senate Appropriations Committee on 26 April. The bill, The Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act of 2013 , would increase overall FDA appropriations to $2.54 billion, or a 1% increase over its Fiscal Year 2012 appropriated amount. BioCentury notes the increase is greater than the amoun...
  • European Parliament Refuses to Approve EMA's 2010 Spending, 2013 Budget

    The European Parliament is refusing to approve of how the European Medicines Agency (EMA) spent its fiscal year 2010 budget-a move that is delaying the approval of EMA's fiscal year 2013 budget , reports PharmaTimes . "The Parliament's Budgetary Control Committee voted 14-9 this week in favor of postponing the EMA's budget management "discharge" (approval) procedure until the Agency presents it with an action plan to improve procurement and contract management," wrote ...
  • Hamburg: FDA Now Approving More Drugs During First-Round Than Ever Before

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg appeared before the House Committee on Appropriations 29 February 2012 to argue on behalf of FDA's Fiscal Year 2013 budget request. Hamburg made a number of notable regulatory assertions in her testimony to the committee. Among them: "FDA now has the highest first action approval rate for new drugs we have ever had." "We lead the world in the number and speed of drug approvals: of the 57 novel drugs...