• Regulatory NewsRegulatory News

    Two Draft FDA Guidelines on NGS Set Foundation for Precision Medicine Initiative

    New next generation sequencing (NGS) technologies that can examine millions of DNA variants at a time and help inform treatment decisions are at the heart of two new draft guidance documents released Wednesday evening by the US Food and Drug Administration (FDA) as part of President Barack Obama’s Precision Medicine Initiative. FDA says the guidance offers a streamlined approach to the oversight of diagnostics that detect medically important differences in a person’s gen...
  • Regulatory NewsRegulatory News

    Groups Protest Senate Bill’s Provision to Exempt Biologics From USP Standards

    Ten groups, including the US Pharmacopeial Convention (USP) and Biosimilars Council, are taking major issue with a provision in a seemingly innocuous bill to boost the workforces of the US Food and Drug Administration (FDA) and National Institutes of Health (NIH). In a letter sent on Monday to Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), the American Pharmacists Association, ASHP, Academy of Managed Care Pharmacy, National Community Pharmacists Association and o...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Five More Bills as Part of Medical Innovation Package

    The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill. Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats. “With its 21st C...
  • Regulatory NewsRegulatory News

    Precision Medicine: Technology, Regulations and Challenges

    • 11 March 2016
    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Feature ArticlesFeature Articles

    Precision Medicine: Technology, Regulations and Challenges

    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Regulatory NewsRegulatory News

    Billion-Dollar Cancer ‘Moonshot’ Plan Includes $75M in New Funds for FDA

    The White House’s $1 billion proposal to fund Vice President Joe Biden's “Moonshot” cancer initiative also includes several proposed investments in federal agencies, including $75 million for a new center at the US Food and Drug Administration (FDA). President Barack Obama’s State of the Union address singled out Biden as the leader of the expansive initiative that so far has few details, and which has raised some serious doubts from cancer researcher Vinay Prasad (who...
  • Regulatory NewsRegulatory News

    In Focus: The Top News Stories from 2015

    For RAPS’ Regulatory Focus , 2015 might simply be called: The Year of the Explainer. With major legislation altering the inner workings of the US Food and Drug Administration (FDA), as well as new priority review voucher programs coming to fruition, RAPS’ reader interest has been spiking for longer, more in-depth articles. Without further ado, here are the top most-read articles in 2015 based on traffic statistics: 9. After Three-Year Delay, FDA Finalizes Guidance Do...
  • Regulatory NewsRegulatory News

    Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act

    Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...
  • Regulatory NewsRegulatory News

    WHO Calls for New Antivenom Treatments as Supplies Dwindle

    The World Health Organization (WHO) on Friday announced it's actively searching for new snake bite treatments as supplies of the most effective anti-venom treatment are due to run out in 2016. Companies can now apply, with no submission fees, to have new treatments assessed by WHO beginning in March. About five million people are bitten by snakes every year, causing upward of 125,000 deaths and leaving 400,000 people permanently disabled or disfigured, according to the W...
  • 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...
  • 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...