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    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
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    Emergency use authorizations for IVDs: Building on lessons learned

    Emergency use authorization (EUA) is a tool used by the US Food and Drug Administration (FDA) for providing quick access to unapproved medical products in response to a public health emergency. In vitro diagnostics (IVDs) have been critical EUA products in past emergencies and have proven equally important during the COVID-19 pandemic. For regulatory professionals, the valuable lessons learned from EUA policy and ensuing changes over time have provided a crucial foundation...
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    The changing regulatory landscape for laboratory developed tests

    The COVID-19 pandemic has highlighted the importance of reliable and accurate diagnostic tests. Laboratory developed tests (LDTs) do not typically require premarket review. The US Food and Drug Administration (FDA) has repeatedly proposed more rigorous regulatory frameworks for LDTs but has been unsuccessful owing to concerns about the impact on test availability and innovation. In this article, the authors describe the existing regulations and consider both sides of the d...
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    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...
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    COVID-19 diagnostics: Moving from laboratory to home-based testing

    The US Food and Drug Administration (FDA) has worked closely with diagnostics developers during the past year to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled authorization of nearly one COVID-19 diagnostic per day, including at-home tests that have a critical role in the ongoing response to SARS-CoV-2. Introduction The emergence of the COVID-19 pandemic create...
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    FDA may decline new COVID vaccine EUA requests

    The US Food and Drug Administration’s (FDA’s) updated emergency use authorization (EUA) for COVID-19 vaccines says the agency may decline EUA requests from developers that have not yet met with the agency to discuss their vaccines.   This announcement was made by the agency in a 25 May tweet from the account of FDA’s Center for Biologics Evaluation and Research (CBER). The revised guidance supersedes versions issued on 22 February 2021 and October 2020. All versions ...
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    DIA/FDA Forum: CBER's pandemic journey continues

    Crushing workloads and statistical conundrums characterized the work of FDA’s staff as they raced to formulate guidelines and then evaluate vaccine candidates amid the pressure of the pandemic, attendees at a biostatistics conference heard on Wednesday.   More complex analysis awaits as real-world vaccine data roll in and FDA’s Center for Biologics Evaluation and Research (CBER) and sponsors both work toward full biologic license applications (BLAs) for the vaccines th...
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    EMA okays Europe's second COVID vaccine

    The European Commission has authorized a second vaccine against COVID-19 following a favorable review by the European Medicines Agency’s human medicines committee (EMA’s CHMP). On Wednesday, the messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health was given a conditional marketing authorization.   “With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. And more vaccines will ...
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    FDA authorizes Pfizer-BioNTech vaccine for emergency use

    The US Food and Drug and Drug Administration (FDA) on Friday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use in individuals ages 16 and older just one day after the agency’s advisory panel voted 17-4 in favor of the vaccine.   Now that the vaccine has been authorized just three weeks after Pfizer and BioNTech submitted their emergency use authorization (EUA) request, a nationwide rollout of the vaccine is set to begin. FDA Commissioner Stephen ...
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    Marks sheds more light on COVID-19 vaccine EUA guidance

    Two days after the US Food and Drug Administration’s (FDA) surprise publication of guidance setting criteria for emergency use authorization (EUA) for COVID-19 vaccines, Peter Marks, director of the Center for Biologics Evaluation and Research shared some of the thought process that went in to its recommendations.   One of the most significant recommendations in the guidance is FDA’s insistence on a median of two months of follow-up of Phase 3 trial participants follow...
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    FDA issues COVID-19 vaccine EUA guidance after clash with White House

    Amid reports that the White House had blocked stricter guidance from the US Food and Drug Administration (FDA) on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency on Tuesday issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.   Last month, agency officials, including FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director...
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    Lawmakers, experts raise questions after convalescent plasma EUA

    After US Food and Drug Administration (FDA) Commissioner Stephen Hahn announced the issuance of an emergency use authorization (EUA) for convalescent plasma to treat coronavirus disease (COVID-19) alongside President Donald Trump on Sunday, experts and democratic lawmakers are raising concerns about how the announcement was presented and the perception of political pressure on the agency.   Convalescent plasma appears to meet the statutory standards for an EUA, which o...