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  • FDA Authorized to Spend New User Fees Under Just-Passed Senate Bill

    The US Senate has approved  a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees it is already authorized to collect, raising the possibility that US regulators will soon be given access to much-needed funding. The bill, known as the continuing resolution (CR), is needed to prevent a potential government shutdown that will otherwise occur at the ...
  • FDA Publishes List of all Device Guidance Documents Planned for 2013

    The US Food and Drug Administration (FDA) has published a list of 23 medical device guidance documents it plans to publish during fiscal year 2013, part of the recently passed FDA Safety and Innovation Act (FDASIA) . Among FDASIA's numerous provisions is the Medical Device User Fee Act (MDUFA) , which established the fees and regulatory expectations for the medical device review process. As of right now, those processes largely exist in the abstract, awaiting further...
  • FDA: Budget Sequestration Could Lead to 'Loss of Whole User Fee Programs'

    The current congressional budget environment is leading to a situation in which the US Food and Drug Administration (FDA) could face the loss of "whole user fee programs" and hundreds of millions of dollars, FDA recently told Bloomberg Businessweek . The agency remarks were in response to recent reports indicating that industry-paid user fees set to flow to the agency under the recently passed FDA Safety and Innovation Act (FDASIA) legislation are at risk of bei...
  • OMB to Federal Agencies: Begin Planning for Massive Budget Cuts

    The White House Office of Management and Budget (OMB) wants federal agencies, including the US Food and Drug Administration (FDA), to remember that on 1 January 2013, all agencies may lose nearly a tenth of their appropriated budget unless Congress acts to override a budget trigger passed into law in 2011. The 2011 action, known as the Budget Control Act (BCA) of 2011 , instituted a trigger procedure known as budget sequestration. Under the procedure, if Congress is...
  • 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 ...
  • Administration Budget Forcefully Against 'Pay-For-Delay,' Industry

    The Fiscal 2013 federal budget released on 13 February by the Obama administration laid out more than just the proposed spending levels for dozens of federal agencies, including the US Food and Drug Administration (FDA). Buried in the several-hundred page budget document are indications that the Obama administration intends to forcefully move against 'pay-for-delay' settlements that the Federal Trade Commission (FTC) considers to be "anticompetitive," biologic exclusivity...
  • UPDATED: Obama FY2013 Budget Proposal Unveiled, FDA Gets Small Funding Boost

    The Obama Administration released its FY2013 budget on 13 February, marking the traditional starting point in the Congressional negotiations over fiscal priorities and funding levels for various agencies, including the US Food and Drug Administration and the Department of Health and Human Services (DHHS). FDA Funding The budget includes $11 million in newly appropriated spending to help FDA implement the Food Safety and Modernization Act of 2011 (FSMA) and $643 milli...