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  • Regulatory NewsRegulatory News

    Should the US government share the Moderna COVID vaccine recipe?

    As much of the developing world struggles to gain access to COVID-19 vaccine doses, some legal experts say the key lies in having the US government share the step-by-step instructions for manufacturing and testing the Moderna mRNA vaccine with other manufacturers.   In a recent Health Affairs blog , Christopher J. Morten, Zain Rizvi, and Ameet Sarpatwari made the case that the US government, through its contract with Moderna, has both access to the details of how the ...
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    FDA unveils proposed changes to OTC sunscreen labeling, active ingredients

    The US Food and Drug Administration (FDA) is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe and effective (GRASE) for marketing.   The proposed order , which was announced on 24 September 2021 and has a 45-day public comment period, closely follows the agency’s 2019 proposed rule on sunscreens. It also includes change...
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    Review highlights lack of consistency in FDA’s ‘close call’ approvals

    The process used by the US Food and Drug Administration to vet new drugs and biologics is inconsistent in borderline cases and fails to rely on evidence standards used in previous decisions, according to findings from a case series that examined the process across 22 "close call" applications in recent years.   The findings, published as a case series in the Annals of Internal Medicine , show that in some cases the agency revised an initial denial based on a reinter...
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    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Convergence: Regulatory considerations in advancing gene and cellular therapies

    When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate the product’s identity, purity, and potency, Haroon Hashmi, PhD, told attendees at RAPS Convergence 2021.   “Even when we think about these complex technologies -- new emerging technologies -- certain regulatory principles always stay in place,” said Hashmi, senior vice president at Ziopharm Oncology, which has developed the Slee...
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    Convergence: First-year experience with Japan’s amended medical device rules

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.   The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided a...
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    HMA-EMA plans real-world metadata framework for regulatory decision-making

    Officials at the Heads of Medicines Agencies – European Medicines Agency (HMA-EMA) are moving forward with an effort to create a usable catalogue of metadata to aid the scientific community in identifying real-world evidence that can inform regulatory decisions.   Metadata is defined generally as “a set of data that describes and gives information about other data” and can be further subcategorized by generation, location, ownership, and governance of the data; process...
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    EU committee considers antimicrobial incentives, repurposing oncology drugs

    During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members debated potential ways to combat antibiotic resistance and improve access to oncology medicines through the repurposing of older or generic medications.   The meeting, held via video conference on 08-09 July 2021, was co-organized and co-chaired by the Slovenian Presidency of the Council of the EU and the European Commission, with atten...
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    Analyses reveal wide variation in PRO measures in cancer trials

    The passage of 21st Century Cures Act in 2015 helped to bolster the inclusion of patient experience data and specifically patient reported outcome (PRO) measures in clinical trials. But even with an increased emphasis on patient reported data, analyses of registrational trials for cancer therapies have shown wide variation in how PRO measures are included and analyzed. A recent analysis of registrational trials for multiple myeloma treatments submitted to the US Food ...
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    FDA studies consumer perception of DTC drug ads, willingness to report false claims

    The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.   In a recent Regulatory Science in Action article , the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consume...
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    Working group: More guidance needed on MRD in myeloma trials

    A working group formed to consider the use of minimal residual disease (MRD) in the treatment of multiple myeloma and the development of new therapies has issued a call for additional regulatory guidance on the use of MRD as a marker in clinical trials.   The working group, a collaboration of advocacy organizations, patients, research foundations, academic, government agencies and industry, was initially convened in 2016 by the Foundation for the National Institutes of...
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    Analysis: Real-world studies of cancer drugs suffer from poor quality

    Real-world oncology data, which is increasingly being touted as a potential basis for regulatory and reimbursement decisions, tends to be of poor quality and may overstate the survival benefits of cancer drugs, according to a new analysis.   The findings, which were published in the European Journal of Cancer , showed that while most cancer drugs approved in the United States and Europe had some type of real-world data (RWD) study available, the methodological quality...