• Regulatory NewsRegulatory News

    FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’

    Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible." Defining RWE Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, wr...
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    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
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    PDUFA VI: Highlights on What to Expect

    The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development. The meeting follows the July release of the full details of the performance ...
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    FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. The 21-page draft document, which is open for comment for the next 90 days, also explains how the agency plans to evaluate real-world data to determine whether it may be sufficiently relevant a...
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    New Report Calls on FDA to Clarify Use of Real-World Evidence

    As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments. The Bipartisan Policy Center’s 32-page repo...
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    FDA Outlines Medical Device Real-World Evidence User Fee Proposal

    Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE). The RWE proposal is part of FDA’s counter proposal for the reauthorization of MDUFA, which was presented to industry on 4 March, and would cost $329 million above the cost of MDUFA III. In a meeting on 25 April (the meeting ...
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    Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA

    The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week. While Califf said his first priority as commissioner is to strengthen FDA's workforce, that stronger workforce will be critical to achieving FDA's goals in specific program areas s...
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    Real World Evidence: Can it Support New Indications, Label Expansions?

    At a public workshop in Washington, DC last week, top US Food and Drug Administration (FDA) officials and other experts explored the challenges and opportunities surrounding real world evidence (RWE) in regulatory decision making. The question they sought to answer is whether data gathered from healthcare systems can be used to supplement or support regulatory decisions, such as the approval of new indications or label expansions for existing drugs. FDA currently uses r...
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    Leverage Purchasing Power to Save Billions on Medicines and Devices, NHS Urged

    According to an independent report commissioned by the UK's Department of Health, the National Health Service (NHS) could save as much as £5 billion (GBP) per year by 2020 through medicines optimization and leveraging NHS buying power to save on medical devices and consumables. Improving Efficiency Last year, Health Secretary Jeremy Hunt appointed Lord Carter, member of the House of Lords (Labour) to chair the NHS Procurement and Efficiency Board. In his capacity as cha...
  • Promotional Materials for STD Drug Miss the Mark, FDA Says in Untitled Letter to Mission Pharmacal

    The US Food and Drug Administration (FDA) has sent Mission Pharmacal Company, the Texas-based pharmaceutical manufacturer of the trichomoniasis drug Tindamax (tinidazole), an Untitled Letter accusing the company of making unfounded and improper claims. Background Trichomoniasis-sometimes shortened to just "Trich"-is a sexually transmitted disease which disproportionately affects women, who most often experience the disease's symptoms of itching or burning. Mission Phar...
  • Ad's ‘See Full Prescribing Information’ Statement Sees Yet Another Untitled Letter from OPDP

    Pharmaceutical company DaraBiosciences is the latest firm to receive an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), the latest in a long line of recipients alleged to have promoted their products using materials with insufficient risk information. Background FDA's Untitled Letter-a stern admonition that nevertheless does not threaten or announce enforcement action for failure to comply with regulation(s)...
  • Study Supporting Daiichi Promotional Materials Pummeled by FDA in New Untitled Letter

    An Untitled Letter sent by the US Food and Drug Administration (FDA) to Daiichi Sankyo regarding promotional materials for two formulations of its hypertension drug Benicar alleges that the materials are misleading and make the drug appear to be more effective than it actually is. The 5 November 2013 letter was sent by FDA's Office of Prescription Drug Promotion (OPDP), and refers to a single advertising piece that co-promotes Benicar (olmersartan medoxomil) and Benicar ...