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  • Regulatory NewsRegulatory News

    UPDATED: New to FDA's Advisory Committee Briefing Documents: Patient Testimony

    Patients and their advocates appear to be getting more prominent attention from the US Food and Drug Administration (FDA) if a recent release of documents in advance of an upcoming advisory committee meeting is any indication. This story has been updated to include additional information from FDA and to correct one inaccuracy: Patient testimonials have always been made available to advisory committee members in advance of meetings, even if they are not publicly po...
  • New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has found herself in front of a congressional hearing for the second time this week, this time under far more favorable circumstances explaining why the agency deserves the funding it receives and-hopefully-more of it. Globalization In prepared testimony delivered on 18 April 2013 to the Senate Committee on Appropriations, the congressional panel with principal authority over FDA's budget, Hamburg obser...
  • Hamburg Defends Agency's Response to Compounding Crisis, Floats User Fees as Potential Solution

    Arguing that the issue of the safety of compounded pharmaceutical products is now at a "critical point," US Food and Drug Administration (FDA) Commissioner Margaret Hamburg plans to tell legislators at a hearing today that her agency needs more resources and authority to better do its job, according to a copy of Hamburg's testimony. Background Legislators with the House of Representative's Energy and Commerce Subcommittee on Oversight and Investigations have for several...
  • Hamburg Calls for New Regulatory Authority in Wake of Compounding Scandal

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has called upon Congress to grant the agency new authorities to regulate and oversee pharmaceutical compounders with the help of a new regulatory paradigm, according to testimony scheduled to be delivered before a House subcommittee. Hamburg is scheduled to appear at a 10 a.m. hearing before the House Energy and Commerce committee to discuss FDA's response to the meningitis outbreak which has resulted ...
  • Shuren's Senate Testimony Yields Wealth of Insight

    The US Food and Drug Administration's (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education, Labor and Pensions Committee yesterday (29 March), providing a wealth of information on CDRH, the medical device review process and agency performance. Shuren's testimony also yielded a wealth of other information of interest to regulatory professionals, including: FDA request...
  • Corrigan: FDA Transforming to a Global Agency, Success Depends on Partnerships

    The US Food and Drug Administration's (FDA) Associate Commissioner for Regulatory Affairs, Dara Corrigan, testified Wednesday (28 March) before a House subcommittee investigating drug counterfeiting, saying she believes FDA is moving to become an agency with a global focus built upon global partnerships. Speaking before the House Committee on the Judiciary's Subcommittee on Crime, Terrorism and Homeland Security, Corrigan said FDA "intend[s] to further transform FDA over...
  • Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...
  • Senate Schedules PDUFA Hearing

    The first hearing in the US Senate for the Prescription Drug User Fee Act ( PDUFA ) reauthorization has been scheduled for next week. The Senate Committee on Health, Education, Labor and Pensions' (HELP Committee) will meet on 29 March 2012 at 10:00 AM EST to discuss the act, which is requires renewal by the end of the year. Witnesses for the hearing have not yet been announced. The user fee legislation is on a fairly tight deadline, as Regulatory Focus reported...
  • 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...