• Regulatory NewsRegulatory News

    Cavazzoni: Pandemic-era tools, learnings are here to stay

    The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...
  • Regulatory NewsRegulatory News

    FDA Finalizes Breakthrough Device Guidance, Outlines Safer Technologies Program

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance detailing its breakthrough devices program and announced plans to bring safer medical device alternatives to market via a new safer technologies program (STeP).   “We continue to encourage device manufacturers to consider the breakthrough devices program for innovative, lifesaving devices, and, in the near future, our goal is to have STeP as an option for those devices with new advances and adaptat...
  • Regulatory NewsRegulatory News

    FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components

    The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan. The warning letter comes less than six months after Meridian recalled 13 lots of EpiPens over concerns that a defective part could prevent the injectors from activating properly, and after a month-long inspection of Meridian's Brentwood, MO facility...
  • Regulatory NewsRegulatory News

    UK's NICE to Launch New Online Tool for Med Tech Developers

    • 31 May 2017
    The UK's National Institute for Health and Care Excellence (NICE), which determines if the UK can afford to pay for certain medical treatments, will launch a new online tool in July to help developers of medical devices and diagnostics understand how to generate the evidence necessary to show their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool, developed in partnership with NICE's Scientific Advice service and the Gre...
  • 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

    Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US

    As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US. Because FDA is classified as a stringent regulatory authority, the agency’s review of drugs and devices...
  • Regulatory NewsRegulatory News

    FDA’s CBER Questions US Transplant Technology Company

    The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics. Pinnacle, according to its website , currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wou...
  • Report: FDA Increasingly Playing Key Role in Global Health

    A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration's (FDA) effects are being felt far beyond US borders. The US health regulatory agency's statutory mandate is ostensibly to ensure the safety and effectiveness of products used by American consumers, but it is "increasingly…playing a role in global health R&D,...