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    Uptake of biosimilars on the rise in the US, but number of marketed products lags other countries

    Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars that have been introduced in the US recently had a stronger uptake than products that came on the market earlier.   These findings, published in JAMA Network Open , come from a cohort study evaluating market share and prices of biosimilars in the US, compared with Germany and Switzerland, which both hav...
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    Industry groups seek changes to nonprescription drug access proposal

    Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products with an additional condition for nonprescription use (ACNU), including how an ACNU is deemed necessary.   The proposed rule , which was issued in June 2022, outlined additional application, labeling and postmarketing reporting requirements for nonprescription drugs with an ACNU. FDA has said the p...
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    FTC files amicus brief challenging REMS patent listings in FDA’s Orange Book

    The US Federal Trade Commission (FTC) has filed an amicus brief in US District Court in Delaware arguing against listing patents on pharmaceutical distribution systems in the Food and Drug Administration’s (FDA) Orange Book.   The amicus brief relates to the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals , an ongoing legal battle in which Jazz is alleging that Avadel infringed on its patent for the distribution system of the narcolepsy drug Xyrem under a...
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    Study: High concordance in breakthrough therapy, PRIME decisions

    The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) agreed on nearly two-thirds of decisions to grant or deny requests for drugs and biologics seeking Breakthrough therapy or Priority Medicines designation, according to a new analysis. The findings highlight the need for agencies and sponsors to take advantage of collaborative opportunities, including the Parallel Scientific Advice program, to support global drug development that addresses ...
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    Generic manufacturers call for changes to list of major deficiencies

    Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA) under the Generic Drug Use Fee Amendments (GDUFA) to classify fewer deficiencies as “major” and avoid extended review cycles.   FDA established a docket to solicit public comments on Appendix A of the July 2018 guidance for industry on “ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GD...
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    Study highlights lack of transparency in FDA’s regulatory safety actions

    Only about one-third of the US Food and Drug Administration’s (FDA) regulatory safety actions were supported by published studies and none were corroborated by public assessments from the Sentinel Initiative, according to a study of the agency’s adverse event reporting system.   “These findings suggest that either the FDA is taking regulatory actions based on evidence not made publicly available or that more comprehensive safety evaluations might be needed when potenti...
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    Experts call for federal incentives to promote clinical trial diversity

    A combination of federal incentives and regulations, similar to the approach used to increase pediatric drug development, is needed to increase the diversity of populations enrolled in US clinical trials of new drugs, according to a proposal from two policy experts.   The proposal, outlined in a perspective piece in the New England Journal of Medicine , argues that current policies – mostly part of voluntary guidance from the Food and Drug Administration (FDA) – hav...
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    Sentinel System expands capacity, data linkages, report indicates

    The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions and become an established resource for real-world data (RWD), according to a new assessment. The assessment, which was conducted by a third-party advisor, is required as part of the agency’s commitments under the Prescription Drug User Fee Act (PDUFA) VI. It spells out the Sentinel System’s progress in e...
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    FDA seek to harmonize human subject protections with revised Common Rule

    The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Common Rule, which contains requirements for protection of human subjects in research conducted or supported by the US Department of Health and Human Services.   The Federal Policy for the Protection of Human Subjects (known as the Common Rule...
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    New FDA guidance offers ethical roadmap for including children in clinical trials

    The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.   The guidance , published on 26 September 2022, is aimed at assisting industry, sponsors and institutional review boards (IRBs) when conducting or reviewing clinical investigations of drugs, biological products, and medical devices that involve children. It was developed by FDA’s Office of Pediatric The...
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    Convergence: RWE regulatory successes offer lessons for US applications

    PHOENIX, AZ – The use of real-world evidence (RWE) to support US regulatory submissions often suffers from a lack of data reliability or clinical relevance, but there have been some success stories where RWE was considered fit for use.   During a session at RAPS Convergence 2022, speakers shared cases where RWE supported regulatory decision making for marketing applications for a new indication or to answer post-marketing safety questions. These examples are not easily...
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    FDA officials urge ‘comprehensive’ approach to accelerated approval reforms

    Critics of the US Food and Drug Administration’s (FDA) accelerated approval pathway have focused on the need to generate confirmatory evidence faster and to withdraw products that fail to show benefit. But officials in FDA’s Oncology Center of Excellence (OCE) suggest that focus is also needed on different trial designs and end points that could help build quality and efficiency into the front end of the process.   In a perspective in the New England Journal of Medic...