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  • Regulatory NewsRegulatory News

    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
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    Stakeholders want more clarity about devices used for remote clinical studies

    A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...
  • RoundupsRoundups

    Asia-Pacific Roundup: India lowers bar for approval of COVID-19 vaccines already authorized overseas

    India’s Central Drugs Standard Control Organization (CDSCO) has relaxed the requirements for the restricted-use emergency authorization of COVID-19 vaccines that are already on the market in some overseas territories.   The change exempts developers of certain COVID-19 vaccines from the need to run post-approval bridging clinical trials and for every batch to undergo testing at the Central Drugs Laboratory at a site in Kasauli. CDSCO is granting the exemption to vaccin...
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    FDA releases batch of 21 product-specific guidances

    The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.   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 reference listed drug (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release....
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    FDA finalizes QIDP Q&A guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.   The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designati...
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    Asia-Pacific Roundup: TGA consults on advertising code revamp

    The Therapeutic Goods Administration (TGA) is seeking feedback on ways to improve the Australian Therapeutic Goods Advertising Code and has proposed options for addressing provisions that it has identified as unclear or inconsistent since the current version of the code came into effect two years ago.   In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some ...
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    FDA welcomes alternative approaches to generic drug development

    Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Generic Drugs, said at a 5 May webinar on the development of product specific guidance.   FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of G...
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    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...
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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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    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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    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. ...