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  • Regulatory NewsRegulatory News

    Can older adult clinical trial participation be boosted?

    The US Food and Drug Administration on Tuesday convened leaders from the agency, industry and academia to tackle barriers and solutions to enrolling older adults in clinical trials. Highlights of the virtual public workshop included solid data from FDA showing the mismatch between disease prevalence and age representation in clinical trials, as well as an in-depth examination of how older adults were represented in COVID-19 vaccine trials.   S. W. Johnny Lau, PhD, a ...
  • Regulatory NewsRegulatory News

    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) this week issued 36 new and revised draft product-specific guidances meant to facilitate the development of generic drugs by clarifying the agency’s expectations for the studies required to demonstrate bioequivalence (BE) to a reference listed drug (RLD).   The latest batch of guidances includes 22 new and 14 revised draft guidances covering drugs to treat prostate cancer, hepatitis C, multiple sclerosis and numerous other cond...
  • Regulatory NewsRegulatory News

    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
  • RoundupsRoundups

    FDA Approvals Roundup: Ponvory, Zegalogue, Exparel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ponvory okayed for use in adults with relapsing multiple sclerosis Janssen’s Ponvory (ponesimod) has been approved as a once-daily oral therapy for adults with relapsing multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.   Approval of Ponvory was based on fi...
  • Regulatory NewsRegulatory News

    FDA recommends 503B bulks list addition; rejects HCQ sulfate

    The US Food and Drug Administration (FDA) has preliminarily recommended that one additional substance be added to its list of bulk drug substances for outsourcing facilities to use in compounding.   FDA is proposing that quinacrine hydrochloride be added to the list, commonly referred to as the 503B bulks list. This bulk drug substance, while not a component of an FDA-approved drug, is used to compound oral treatments for cutaneous lupus erythematosus. (RELATED: Glyc...
  • Regulatory NewsRegulatory News

    Device, digital health firms oppose HHS’ proposed 510(k) exemptions

    Medical device and digital health companies have largely come out in opposition to a proposal from the Department of Health and Human Services (HHS) to permanently exempt 84 types of medical devices from premarket notification (510(k) requirements.   The proposal was made in the final days of the Trump administration and was pushed through without consulting the US Food and Drug Administration (FDA), the agency that would typically issue such a notice. All the devices ...
  • Regulatory NewsRegulatory News

    PDUFA VII negotiations wind up; CMC, IT modernization issues resolved

    Negotiations between industry and the US Food and Drug Administration (FDA) for the sixth reauthorization of the prescription drug user fee program (PDUFA VII) have concluded after another round of subgroup meetings.   The most recent subgroup meetings focused on edits and updates to draft commitment language. In the 3 February FDA and industry manufacturing meeting, for example, the minutes reveal that “Both parties reviewed each draft commitment line by line and di...
  • Regulatory NewsRegulatory News

    HHS hits pause on Trump era SUNSET rule

    The US Department of Health and Human Services (HHS) is postponing the implementation of a controversial Trump era rule that would have required the department to review thousands of its regulations while the rule undergoes judicial review.   The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) was first proposed in November 2020 and finalized on 19 January 2021, one day before President Joe Biden’s inauguration. At its core, the rule would sunset m...
  • Regulatory NewsRegulatory News

    COVID innovation lessons could be applied elsewhere

    The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?   Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well. ...
  • Regulatory NewsRegulatory News

    No ivermectin for COVID, says EMA

    The antihelmintic drug ivermectin should not be used for COVID-19 treatment outside of the clinical trial environment, according to a statement issued Monday by the European Medicines Agency (EMA).   The European regulator’s statement parallels the position of the US Food and Drug Administration (FDA), which issued a 5 March update for consumers in response to “multiple reports of patients who have required medical support and been hospitalized after self-medicatin...
  • Feature ArticlesFeature Articles

    FDA’s new integrated review template and implications for regulatory intelligence

    US Food and Drug Administration (FDA) review summaries, previously referred to as summary basis of approval documents, can serve as invaluable sources of regulatory strategy information, the details of which are not publicly available from any other source. When the FDA announced its plans to use a more streamlined approach to communicating regulatory decisions through an integrated assessment process and review document, it raised concern among those who contribute to and...
  • Regulatory NewsRegulatory News

    COVID-19, reorg dominated 2020 for FDA Office of New Drugs

    Staff in the U.S. Food and Drug Administration’s Office of New Drugs (OND) began 2020 with a focus on completing the office’s reorganization, but they quickly shifted focus to the global pandemic and supporting accelerated development of new therapeutics to prevent or treat COVID-19, according to the OND’s inaugural annual report.   “Despite the added workload, there were no significant disruptions to OND’s work as staff managed to meet and/or exceed many of the Prescr...