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  • 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 The book contains all drug products that are approved or have not been withdrawn for reasons of safety or efficacy with the exception of produc...
  • 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...
  • Hearings to Explore Budget, Prescription Drug Issues

    A trio of Congressional hearings the week of 27 February will explore the proposed budget of the US Food and Drug Administration (FDA), the proposed budget of the US Department of Health and Human Services (DHHS) and prescription drug diversion. On 29 February 2012, FDA Commissioner Margaret Hamburg will appear before the US House Committee on Appropriations . Hamburg will be joined by FDA Assistant Commissioner for Budget Patrick McGarey and Deputy Assistant Secretary ...