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  • Regulatory NewsRegulatory News

    FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation

    The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board. Background Six years after a 2007 report from the Science Board -- which, among other findings, called attention to FDA’s “weak scientific base and inadequate scientific wor...
  • Regulatory NewsRegulatory News

    FDA Looks to Develop Regulatory Strategies for Genomic Testing

    To further the president's Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing (NGS) technologies. Background Since 2014, FDA has sought input from the public on how it could develop a regulatory system appropriate for reviewing and regulating NGS technologies. The agency says it believes such a system "could potentially be applied to many other types o...
  • Regulatory NewsRegulatory News

    European Commission Responds to 'Stop Vivisection' Campaign

    The European Commission (EC) has responded to a campaign calling for an end to animal testing in the EU, saying animal testing is still necessary, but promising to accelerate efforts to reduce the need for animal testing. Background In March 2015, the Stop Vivisection campaign submitted a European Citizens' Initiative to the EC, calling for the commission to repeal Directive 2010/63/EU and replace it with new legislation that would phase out animal testing. A Eu...
  • Regulatory NewsRegulatory News

    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...
  • Regulatory NewsRegulatory News

    Congress Eyes Wider Use of Third-Party Medical Device Assessments

    A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...
  • Regulatory NewsRegulatory News

    Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill

    An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months. Background The provision, popularly known as the Orphan Product Extensions Now Act , was originally introduced in the US House of Representatives in November 2014. Under the bill, existing pharmaceutical products would be grant...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: The (Updated) 21st Century Cures Act

    The US House Energy and Commerce (E&C) Committee has released an updated draft of a piece of legislation which proposes dramatically overhauling the way in which the US Food and Drug Administration (FDA) regulates many healthcare products. The bill, the 21st Century Cures Act , has been under development since at least April 2014, when the E&C Committee kicked off its "21st Century Cures Initiative." The initiative is intended to speed up the pace at which FDA approve...
  • Regulatory NewsRegulatory News

    Legislation Overhauling Approval of Drugs, Devices Coming Next Week

    Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act , a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products. Background The legislation was first unveiled in January 2015 after months of discussions between legislators, regulators, industry, innovators, academics and patients. As extensively e...
  • Regulatory NewsRegulatory News

    FDA Seeking Safer Medical Devices Through eLabeling Pilot

    Medical devices used in home healthcare settings may soon be made safer thanks to a labeling program being piloted by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Background In general, medical devices can be divided into two categories: those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers. The latter category,...
  • Regulatory NewsRegulatory News

    Breaking Down Barriers to Drug Innovation a Team Effort, FDA Says in Guidance

    A new guidance document just finalized by the US Food and Drug Administration (FDA) aims to clarify how pharmaceutical companies and the public can help accelerate drug development through the agency's Critical Path Initiative (CPI). Background FDA's Critical Path Initiative was created in March 2004 as an attempt to identify and dismantle unnecessary roadblocks to new product innovation and regulatory approval. These roadblocks, which would exist on a product's "critic...
  • Regulatory NewsRegulatory News

    Five-Year European Pharmacovigilance Project Comes to an End

    A five-year long European research project to improve drug monitoring methods is coming to a close this month. The project, known as the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), is a joint effort by 34 public and private partners and coordinated by the European Medicines Agency (EMA) and GlaxoSmithKline. About PROTECT PROTECT was launched in 2009 after receiving funding from the Innovative Medicines Initiat...
  • Regulatory NewsRegulatory News

    Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

    The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices. Background The agenda, released on 10 February 2015, is part of a larger push to "renew [the] medical technology innovation ecosystem," AdvaMed explained in a press statement. The ultimate goal of the initiative is to "help speed pat...