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  • Regulatory NewsRegulatory News

    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
  • Regulatory NewsRegulatory News

    House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

    The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...
  • Regulatory NewsRegulatory News

    Sunscreen Innovation Act Advances in House, Seeks FDA Action on New Ingredients

    Legislators are preparing to move forward with legislation that would require the US Food and Drug Administration (FDA) to take action on the approval of new sunscreen ingredients, a collection of which have been pending before the agency for years, and in some cases more than a decade. Background HR 4250 , known as the Sunscreen Innovation Act , is co-sponsored by Reps. Ed Whitfield (R-KY) and John Dingell (D-MI) and required FDA legislators to speed up their r...
  • Regulatory NewsRegulatory News

    CDRH Sees Customer Satisfaction as a Driver of Innovation, Good Regulation

    The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory branch, has a question for industry: How have we helped you lately? Background It's a bit of an odd question without context. In February 2014, CDRH launched a new document, CDRH 2014-2015 Strategic Priorities , in which it said the device center would be focusing on three things in 2014: strengthening clinical trials, balancing pre- and post-mark...
  • CFDA Announces Expedited Review Process for Innovative Devices

    The China Food and Drug Administration (CFDA) announced on 7 February 2014 the implementation of a new expedited priority review and approval process for innovative medical devices, to take effect as of 1 March 2014. The CFDA stressed that the expedited procedure would not lower existing review and approval standards, but instead would expedite the marketing of new innovative medical device technologies. The new process is also expected to promote the research and dev...
  • Feature ArticlesFeature Articles

    Ambiguity from FDA Stunts Growth in the US, While Innovation Flourishes in Europe

    Editor's note: RAPS is a neutral, non-lobbying organization. The views expressed in this Perspectives piece by Chris Velis, CEO and chairman of MedCap Advisors, are those of the author. We hope this article will stimulate conversation, and we invite you to discuss it in the Regulatory Open Forum on Regulatory Exchange , our private social media community for RAPS members. Current State of Affairs Inconsistency and ambiguity in the US Food and Drug Administration's (F...
  • WHO Report: Regulators need to Collaborate, Evaluate and Innovate

    An extensive new report issued by the World Health Organization (WHO) calls on global regulatory bodies to refine and improve their respective systems for approving new medicines, balancing the needs of public health and innovation to "ensure a continuous flow of the new medicines most needed by society." The Report The report, Priority Medicines for Europe and the World Update Report, 2013 , is a follow-up to a 2004 report by the same name, and was prompted by the...
  • FDA Proposes 'New Pathway' to Approve Drugs for Unmet Needs

    The US Food and Drug Administration (FDA) plans to hold a public meeting in February to discuss the formation of a "potential new pathway" intended to bring to market new products aimed at treating serious or life-threatening conditions for which there is an unmet need. The new pathway seems likely to take advantage of FDA's new draft guidance on enriched clinical trials , which states that small, targeted subpopulations of patients may be used as the basis of approval ...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...
  • Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part 2

    The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews. Consider a Pre-Submission Meeting One particular strategy we have found quite productive, particularly for more-complex or innovative devices, is to...
  • Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part I

    In recent months, I have attended various medical conferences and trade shows that have highlighted many of the most promising med-tech innovations. From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. Yet, as a regulatory professional, I was struck by the numerous calls for the US Food and Drug Administration (FDA) reform and the claims FDA is st...
  • Feature ArticlesFeature Articles

    Approval of Jakafi (ruxolitinib) Based on a Home-Grown, Patient-Reported Outcome Instrument: A Case Study

    Jakafi® (ruxolitinib) was approved 1 by the US Food and Drug Administration (FDA) on 16 November 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF (PPV-MF) and post-essential thrombocythemia MF (PET-MF). Prior to this time, there were no approved products, and therefore no precedent for regulatory endpoints in this orphan disease. MF is a highly symptomatic 2 myeloproliferative neoplasm (MPN), cha...