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    FDA unveils plans to tackle COVID variants

    The US Food and Drug Administration (FDA) on Monday unveiled recommendations for vaccine, drug and diagnostic test developers to address the impact of COVID-19 variants on the efficacy and performance of their products.   The recommendations are made across four new and updated guidances targeting vaccines , drugs and biologics , monoclonal antibodies and diagnostic tests .   “The purpose of these guidances is to address the emergence and potential future emer...
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    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
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    CBER lays out scaled-down guidance agenda for 2021

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021.   The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year.   CBER was able to cross more tha...
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    FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients

    In an update to its guidance on conducting clinical trials amid the COVID-19 pandemic, the US Food and Drug Administration (FDA) on Wednesday explained COVID-19 treatments and vaccines used under an emergency use authorization (EUA) are not considered investigational products for the purposes of clinical trial exclusion criteria.   The guidance, first issued in March 2020, has been updated several times throughout the pandemic to address questions raised by industry ab...
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    CDER lays out 2021 guidance agenda

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021.   The agenda, while oftentimes aspirational, provides insights as to what the agency’s drug center’s new guidance priorities are for the coming year. However, the list does not include draft or revised guidances the agency plans to finalize in 2021. (RELATED: 2020 CDER draft and revised guidance...
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    FDA details review timelines as facility assessment-related CRLs pile up

    In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when a facility assessment or inspection is required in order for the agency to make a decision on the application.   FDA’s ability to conduct on-site inspections has been dramatically curtailed amid the COVID-19 pandemic due to public health concerns and travel restrictions. ...
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    FDA finalizes guidance on complex innovative trials designs

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics.   The nine-page final guidance comes just over a year after the draft version was released for comment and two years after the agency launched its CID pilot program. (RELATED: FDA launches pilot program in support of complex trial designs for drugs and biologics , Regulatory Focus 2...
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    FDA posts final guidance on device-specific performance criteria

    FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws.   Last year, FDA published guidance on the optional Safety and Performance Based Pathway. The text set out the agency’s thinking on a pathway intended to enable companies to show a new product is as safe ...
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    FDA issues 34 new and revised product-specific guidances

    In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances released by the agency to 1,974.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a refe...
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    FDA finalizes certificates of confidentiality guidance

    The US Food and Drug Administration (FDA) finalized its guidance explaining how sponsors can request certificates of confidentiality (CoC) meant to protect the privacy of clinical trial participants.   “By protecting researchers from being compelled to disclose identifiable, sensitive information about the research participants, CoCs help protect the identity of the research participants and achieve the objectives of the research,” FDA writes.   FDA explains that t...
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    FDA offers strategies to streamline schizophrenia drug trials

    Shortening the length of clinical trials and simplifying the symptom scale are two strategies that could help make schizophrenia drug trials less costly and more efficient, according to study findings from scientists at the U.S. Food and Drug Administration (FDA).   Schizophrenia drug developers face several obstacles when evaluating treatments, including high patient dropout rates in trials, modest treatment effects, high placebo response, and uncertainty about which ...
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    FDA releases draft guidance for physiologically based PK analyses

    The US Food and Drug Administration (FDA) has issued draft guidance for industry on the use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications. A PBPK analysis uses models and simulations combining physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic or pharmacodynamic behaviors of a particular drug product, according to the FDA. The idea behind using this techni...