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  • Regulatory NewsRegulatory News

    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
  • Regulatory NewsRegulatory News

    New Research Compares Drug Regulators Around the Globe

    Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals. Of the regulators in the more established major pharmaceutical markets (the authors from the European Center of Pharmaceutical Medicine and Novo Nordisk point to the US, Europe and Japan as being the regulators in such mark...
  • Regulatory NewsRegulatory News

    19 European Cities Vie to Host EMA Headquarters

    The European Commission on Tuesday said it will assess the 19 offers from EU cities to host the European Medicines Agency's (EMA) headquarters as it moves from London's Canary Wharf following Britain's decision to leave the EU. The Commission's assessment will be published online 30 September 2017, then the European Council will have a political discussion based on the assessment at the General Affairs Council (Article 50 format) in October 2017. The vote will cons...
  • Regulatory NewsRegulatory News

    FDA Finalizes GDUFA Q&A Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues. The guidance, which finalizes a revised draft version released in September 2013, provides answers on more than 30 commonly asked questions on GDUFA implementation. While the draft g...
  • Regulatory NewsRegulatory News

    FDA Approves First New Sickle Cell Drug in Almost 20 Years

    The US Food and Drug Administration (FDA) on Friday granted approval to Emmaus Medical’s Endari (L-glutamine oral powder), the first treatment approved for patients with sickle cell disease in almost 20 years. Endari is approved for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. Endari is the 24th new drug approved by FDA in 2017, already two more than all of 2016 . Richard Pazdur...
  • RAPS' LatestRAPS' Latest

    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...
  • Regulatory NewsRegulatory News

    Swissmedic Touts 2016 Performance: 42 New Approvals

    In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure. In 2016, Swissmedic approved 42 new active substances (NASs), a 50% increase over the previous year and just over 50% more than EMA recommended. "This increase shows that the pharmaceutical industry in Switzerland is conti...
  • Regulatory NewsRegulatory News

    FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

    For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence. Antimicrobial resistance has been recognized as a public health threat. The World Health Organization said it is "so serious that it threatens the achiev...
  • Regulatory NewsRegulatory News

    Senate Confirms Gottlieb as Next FDA Commissioner

    The Senate on Tuesday afternoon voted along party lines to confirm Dr. Scott Gottlieb as the next US Food and Drug Administration (FDA) commissioner. Gottlieb, who faced limited resistance during his Senate committee hearing for his close financial ties to industry, will fill a position most recently held by Dr. Robert Califf , who served under President Barack Obama until last January. In his confirmation hearing, and unlike several other Trump nominees, Gottli...
  • Regulatory NewsRegulatory News

    Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins

    The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union , setting in motion the timeline for implementation of the new regulations to commence on 25 May. Gert Bos, executive director at Qserve Group and a RAPS board member, explained to attendees of the MedCon conference in Cincinnati on Thursday some of the difficulties that industries will face over the ...
  • Regulatory NewsRegulatory News

    Fast Start for FDA Drug Approvals in 2017

    The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015. Already in 2017, FDA has approved 14 new drugs , though that quick pace is not likely to continue and the rest of the year is shaping up to be an average or slightly above average year for approvals. Based on data from BioPharmCatalyst , FDA has just over 20 remaining a...
  • Regulatory NewsRegulatory News

    Main Challenge for Generic Drugmakers? First Cycle Approvals, FDA Says

    The biggest outstanding challenge for the generic drug industry moving into the second iteration of its user fee agreement is multiple cycle reviews before approval, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs told participants Tuesday at a generic drugs forum for small businesses. According to FDA’s latest complete set of data, only 9% of abbreviated new drug applications (ANDAs) won approval in the first review cycle, ...