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    EMA, EUnetHTA Sign Off on Three-Year Work Plan

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan. Much of the 2017-2020 work plan builds on previous and ongoing efforts to streamline processes between regulators and health technology assessment (HTA) bodies. "By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in...
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    FDA Finalizes Guidance on Emerging Manufacturing Tech Program

    The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing. "In recent years, we've seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D printed drug. These advancements have led to improved products for pa...
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    Drug Reimbursement in Canada

    This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place. The Regulatory–Reimbursement Interface Community (out-patient) drug reimbursement is usually considered after a drug has received regulatory approval from Health Canada. Regulatory proces...
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    The Value of Health Technology Assessment Scientific Advice

    In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers. Introduction In recent years, there has been an increas...
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    Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations

    The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology. Such mobile technology can offer new ways to collect objective measurements of clinical trial participants as they go about their daily lives. And though the use of such novel endpoints, whi...
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    FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations

    The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations. Specifically, the guidance provides 28 questions and answers detailing how drugmakers, clinical investigators, clinical research organizations (CROs) and institutional review boards (IRBs) can ensure such electronic systems m...
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    EU Health Tech Assessments: Majority Favor Continuing Beyond 2020

    A majority of respondents to a European Commission questionnaire, including pharmaceutical and medical device companies, says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020. The results, revealed in a EC report on Monday, found that almost all respondents (98%) consider it useful to compare whether new health technologies work better, equally well or worse than existing ones, as part of guidance to decision makers. Backg...
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    Industry Group Links More Than 28,000 Job Losses to Device Tax

    As part of its push to fully repeal the medical device tax from the Affordable Care Act , industry group AdvaMed took to the offensive on Wednesday, saying US medical technology jobs declined by more than 28,000 (7.2%) while the 2.3% tax was in effect. Citing data from the Commerce Department, AdvaMed notes that from 2012 to 2015, the number of medical technology jobs in the US declined from 401,472 to 372,638, and though the group does not explicitly say the job loss...
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    European Commission Explores the Future of HTA Cooperation

    The European Commission on Friday opened a consultation to consider the views of a number of different stakeholders on the future of health technology assessments (HTAs) across the EU member states. The commission is looking to track the experiences in the current system and the on-going cooperation mechanisms, as well as any future needs and opinions on the proposed approach in the Inception Impact Assessment . Specifically, the EC is looking to hear more on a number...
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    A Look Into the Future: FDA Wants to Know What’s Coming for Scientific Advances

    New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term. Now, FDA is formally asking interested parties to offer some fresh perspectives on these and other emerging technologies and cross-cutting scientific advances that could be of importance to FDA, with a focus on areas that may impact FDA in five to 10 years. “FDA's ...
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    10 Disruptive Technologies and the Regulatory Implications

    The 2016 Regulatory Convergence will begin with opening keynote remarks from R “Ray” Wang , noted expert on disruptive technologies and new business models . Hearing Wang’s thoughts on innovation and technology and how regulatory can keep up with the rapid changes should prove to be a timely and appropriate way to begin this year’s Convergence. The healthcare products sector has seen the introduction and development of a number of disruptive technologies in ...
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    Industry Calls for More Guidance From FDA on New Clinical Trials Technology

    The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products. In October 2015, FDA put out a request for more information on the types of technologies and innovations companies are employing to conduct clinical rese...