• Feature ArticlesFeature Articles

    The PhD scientist’s pathway into regulatory affairs

    Making a transition from a life and health science research scientist to a regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.   Intellectual curiosity is often the impetus for pursuing a doctorate degree (PhD). The desire to learn a su...
  • RF Quarterly

    The Canadian application process and alternate pathway for COVID-19‒related trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations for Clinical Trials Involving Human Subjects in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range of clinical trial submission requirements and communication with Health Canada’s relevan...
  • Regulatory NewsRegulatory News

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
  • Regulatory NewsRegulatory News

    FDA Launches Expanded Access Pilot ‘Project Facilitate’

    The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.   “The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not fami...
  • Regulatory NewsRegulatory News

    Right to Try One Year Later: Limited Patient Involvement but More FDA Clarity Coming

    The Right to Try Act has officially been in place for one year and although just two patients have publicly announced that they have used the law to gain access to experimental therapies, hundreds more may follow. The US Food and Drug Administration (FDA) on Thursday offered a new website to explain what patients and what investigational drugs are eligible under the law. The website includes eight questions and answers on the law, clarifying that companies are not r...
  • Regulatory NewsRegulatory News

    510(k) Modernization: FDA Floats Need to Pursue New Authority

    Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...
  • Regulatory NewsRegulatory News

    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
  • Regulatory NewsRegulatory News

    CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway

    Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019. “Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus . “We encourage industry and o...
  • Regulatory NewsRegulatory News

    Bioethicists Say Federal Right-to-Try Legislation Will Have Limited Impact on Access

    In a perspective published in the New England Journal of Medicine on Wednesday, bioethicists Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warn that federal "right-to-try" legislation could undermine the US Food and Drug Administration's (FDA) public health mission and will have a limited impact on improving patient access to investigational products. Background The debate around right-to-try centers around patients' ability to access unappr...
  • Regulatory NewsRegulatory News

    FDA Discusses Device Least Burdensome Provisions in New Draft Guidance

    After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices. FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA) in 1997, and since then, both the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act...
  • Regulatory NewsRegulatory News

    What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

    While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence. The creation of this voluntary, alternative 510(k) pathway, first announced back in September , "will allow more flexibility to use more moder...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Tasks ex-GSK CEO With Highlighting Drugs Eligible for Accelerated Access Pathway The UK has tasked former GlaxoSmithKline CEO Sir Andrew Witty with highlighting products suitable for its incoming accelerated access pathway (AAP). Products that follow AAP will benefit from support with evidence generation and a more seamless journey to market, features the government ...