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  • Regulatory NewsRegulatory News

    European Commission reviews impact of orphan, pediatric regulations

    The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.   The more than 100-page evaluation reviews the positive impacts and shortcomings of the orphan regulation, Regulation (EC) No 141/2000 , and the pediatric regulation, Regulation (EC) No 1901/2006 , based on external studies and var...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development

    A bill introduced last year in the US House of Representatives that would reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers could end up costing public and private payers $4.5 billion over 10 years, Harvard Medical School researchers said in an article published Sunday. The economic impact of the bill, which was introduced by Rep. John Shimkus (R-IL), who is not seeking re-election, and co-sponsored by two Democrats, was ...
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    Survey From CDRH Officials Finds Informed Consent Process Needs Improving

    Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found. The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were...
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    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...
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    New Research Questions FDA’s Reliance on and Inability to Enforce Postmarketing Requirements

    As the US Food and Drug Administration (FDA) has increasingly relied on postmarketing requirements (PMRs) to support its approval decisions, a new study published in the Milbank Quarterly discusses how FDA’s lack of ability to enforce PMRs reveals an agency “on guard against a set of larger political threats to its mandate.” The study’s publication follows a recent report from FDA showing that most of the required PMRs and voluntary postmarketing commitments (PMCs) ...
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    FDA’s Woodcock Weighs in on Role of NIH in Drug Development

    US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday that while the National Institutes of Health (NIH) has been instrumental to drug discovery and development, she does not think NIH or academics should be in the business of developing new pharmaceuticals. The comments came as part of the first day of a two-day meeting at the National Academies of Sciences, Engineering and Medicine in Washington, DC...
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    FDA Finalizes Guidance on Pediatric Information in Drug Labels

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on the content and placement of pediatric information within the labeling of drugs and biologics.   “The goal of this guidance is to provide recommendations to help ensure that information on the use of prescription drugs in pediatric populations (whether positive, negative, or inconclusive) is consistently placed in the proper sections and subsections within labeling so that the information is c...
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    Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds

    The rare pediatric priority review voucher (PRV) program was not found to be associated with an increase in the number or rate of new rare pediatric disease drugs that began clinical trials, a Health Affairs study found. But the researchers from Harvard Medical School, working on what they said is the first study on the impact of the rare disease PRV program on drug development, also found that their data do provide some encouraging news about rare pediatric disease d...
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    EMA Recommends When Drugmakers Should Consult With Pediatric Research Network

    The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.   “Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benef...
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    FDA Works to Reduce Dog Testing in Drug Development

    US Food and Drug Administration (FDA) researchers are working to develop a new informatics model to reduce the reliance on dogs to conduct studies in animal drug development.   The agency’s new study, which was proposed on Friday, is intended to aid animal drug developers in conducting certain research without the need for product testing on dogs.   Animal drug developers would be able to use the new model as a mechanism for comparing blood levels of certain oral...
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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...