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  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
  • Feature ArticlesFeature Articles

    Integrating master files in the NDI notification process to facilitate innovation in dietary supplements

    This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.   Introduction Innovation grows industries, and it is no different for the dietary supplement industry...
  • Regulatory NewsRegulatory News

    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
  • RAPS' LatestRAPS' Latest

    John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor

    RAPS has announced the recipients of its 2018 Founder’s Award. They are: John Lim, MD, executive director, Center of Regulatory Excellence, Singapore; Justina Molzon, JD, former associate center director for international programs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA); Barbara Schneeman, PhD, former director, Office of Nutrition, Labeling and Dietary Supplements, FDA; and Mike Ward, coordinator, Regulatory System Strengthen...
  • RAPS' LatestRAPS' Latest

    RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership

    RAPS has announced the recipients of its 2018 Community Leadership Award. They are: Lena Cordie, president, Qualitas Professional Services, and Alan McEmber, MS, RAC, head, therapeutic area regulatory strategy, Shire. The Community Leadership Award recognizes RAPS members who have helped build thriving local networks, supported fellow regulatory professionals and acted as RAPS ambassadors. Cordie and McEmber will be honored and receive their awards next week during RAP...
  • RAPS' LatestRAPS' Latest

    GSK's Sue James Praises RAPS' Regulatory Competency Framework

    In 2016, RAPS released its Regulatory Competency Framework , a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations began using the Framework immediately. We spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and how it has been used at GSK. Regulatory Focus : What do you see as th...
  • Regulatory NewsRegulatory News

    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
  • Regulatory NewsRegulatory News

    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
  • Regulatory NewsRegulatory News

    NDI Guidance: The Waiting Game

    This article discusses FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization. Introduction Regarding how dietary supplements should be regulate...
  • RAPS' LatestRAPS' Latest

    RAPS Honors Regulatory Leaders With Two New Awards

    RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference, being held at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September . Four outstanding individuals who have had a profound impact on the regulatory profession during their careers will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees...
  • 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...