• Regulatory NewsRegulatory News

    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
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    Researchers Question FDA's Use of Surrogate Endpoints for Cancer Drug Approvals

    Two researchers are questioning the US Food and Drug Administration's (FDA) use of surrogate endpoints in approving new oncology drugs and the agency's failure to more strictly enforce postmarketing study requirements for these drugs, according to a letter appearing in JAMA Internal Medicine . Drugmakers have increasingly relied on surrogate endpoints to support the approval for new cancer drugs. Instead of demonstrating improvements in overall survival, often called "t...
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    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...
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    FDA Accepts for Review First NDA for a 'Digital' Medicine

    The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs. In the case of this new drug application, the sensor is paired with Otsuka...
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    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...
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    precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine

    The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies. precisionFDA In a post to FDA Voice Wednesday, FDA Chief Health Informatics Officer Taha Kass-Hout and Policy Advisor for the Office of In Vitro Diagnostics and Radiological Health David Litwack laid out the plan and goals for precisionFDA. The new platfo...
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    FDA: What's Slowing Progress in Some Disease Areas?

    In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology. Why are There Effective Treatments for Some Diseases and not Others? Califf raises this question, and points to some diseases like HIV/AIDS, where advances in scientific understanding hav...
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    DSHEA: Preserving Legal Access to Chinese Herbal Medicine or Researching new Remedies for Malaria and Other Tropical Diseases

    This article explores the importance of continued access by researchers to Chinese medicinal herbs via DSHEA, in light of a potential increase in tropical diseases in historically non-tropical regions. Preserving access to traditional Chinese medicine will become important as tropical diseases gradually become endemic to the United States. As the climate warms 1 and mosquitos proliferate, 2 diseases formerly confined to the tropics are moving north. 3 Si...
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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...
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    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...
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    New Regulatory Approaches Key to Future of Personalized Medicine

    Personalized medicine has been heralded as the future of medicine, a new way forward that will simultaneously trim healthcare costs and improve care by doing away with ineffective treatments. While these large-scale benefits are still to come, personalized medicine—also called or precision medicine—holds great potential, particularly if governments, researchers, regulators and industry can figure out how best to nurture it. Efforts are underway to promote develop...
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    Poor-Quality Medicines a 'Global Pandemic,' New Research Says

    Poor-quality and falsified medicines are "potentially devastating" to global health, researchers and regulators said on Monday in a collection of articles posted in the American Journal of Tropical Medicine and Hygiene . Background: Counterfeit Drugs Not all poor-quality medicines are created equal. The authors of one of the articles break poor-quality medicines into three categories: falsified (including counterfeit), substandard and degraded. While each of these ca...