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    FDA releases guidance on compounding beta-lactam products in shortage

    The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam oral antibiotic suspension products.   The agency said it has been asked to clarify how compounded versions of products from FDA-approved tablets and capsules currently in shortage can be prepared, as FDA’s insanitary conditions guidance states beta-lactam drugs are required to be processed with “complete ...
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    FDA outlines plan for ‘agency-wide approach’ to cybersecurity

    The US Food and Drug Administration (FDA) has released a new action plan for approaching cybersecurity, outlining its mission to upgrade, enhance and modernize its defenses to assets and data at the agency.   “Cybersecurity touches every facet of the FDA’s broad, complex responsibility. It’s one of our agency’s top priorities, and we take it seriously, particularly given today’s increased cybersecurity risks,” Vid Desai, chief information officer and Craig Taylor, chie...
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    Industry seeks clarity, ICH Q9 alignment in FDA’s device production software guidance

    Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked the agency to align some of the language in the document with the recent International Council for Harmonisation’s (ICH) Q9 guidance, exclude system lifecycle tools from the guidance and include information on cybersecurity.   The draft guidance details a risk-based approac...
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    FDA drafts guidance on ‘sameness’ evaluations for generic drugs

    The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated new drug application (ANDA) proposed generic drug products compared with the reference listed drug (RLD).   FDA defines an active ingredient as one “intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect t...
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    Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

    Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan products using expedited programs alone in combination to achieve FDA approval more frequently over the last 13 years, according to recent research published in JAMA Network Open .   “In this study, use of expedited programs alone and in combination for novel drug development a...
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    FDA updates guidance on expanded access for investigational drugs under IND

    The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded access should be implemented given new regulatory access and statutory requirements through the 21st Century Cures Act (Cures Act) and FDA Reauthorization Act of 2017 (FDARA).   While the guidance remains largely the...
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    FDA releases new draft guidances on topical generic drugs

    The US Food and Drug Administration (FDA) recently released several new draft guidances concerning topical generic drug products submitted under abbreviated new drug applications (ANDAs).   FDA’s recent draft guidances for industry on topical generic drugs include a guidance containing recommendations on in vivo bioequivalence studies for topical corticosteroids, a guidance for physicochemical and structural characterizations of topical drug products in ANDAs, a guid...
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    Study: Older adults underrepresented in trials of drugs they may regularly use

    Older adults are not well represented in clinical trials of drugs and biologics they may regularly use, according to recent research published in JAMA Network Open .   “Data on safety and efficacy of medications across the entire older age span are important to appropriately care for this growing older population,” S. W. Johnny Lau, PhD, with the Office of Clinical Pharmacology, Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER) i...
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    FDA releases discussion paper on distributed and point-of-care manufacturing

    The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs and biological products that fall under the purview of the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).   FDA’s discussion paper, written for stakeholders and for public comment, focuses on topic...
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    FDA offers details on PDUFA VII STAR review pilot

    The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten the review time of existing drugs and biologics where there is an unmet medical need so patients can access the therapies earlier.   The program would apply to “efficacy supplements across all therapeutic areas and review disciplines that meet specific criteria,” the agency wrote on a new web page. The program includes ...
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    Stakeholders want more clarity on concepts introduced in third PFDD draft guidance

    The US Food and Drug Administration (FDA) received a broad range of comments concerning its draft guidance on selecting, developing, or modifying clinical outcome assessments (COA) in patient-focused drug development (PFDD), with most stakeholders wanting to know how new terminology introduced in the guidance would fit in with the agency’s overall PFDD program.   FDA’s draft guidance on COAs for PFDD is the third in a series of four guidances authored by staff members ...
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    OIG raises concerns about accelerated approval pathway

    More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years past their confirmatory trial deadlines, according to a recent report released by the US Department of Health and Human Services Office of Inspector General (OIG).   “The accelerated approval pathway holds promise for patients who face serious illnesses where adequate treatments are lacking. In the best-case sce...