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    FDA proposes to refuse Intarcia’s exenatide combo product NDA —again

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has told Intarcia Therapeutics it is proposing to refuse a new drug application for their type 2 diabetes drug-device combination product ITCA 650.   In a notice posted in the Federal Register , the agency said Intarcia can request a hearing from FDA on the proposal, but if the hearing is waived or it is determined the reason for the hearing isn’t sufficient, FDA will move forwa...
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    May’s Regulatory Focus: EU MDR and EU IVDR update, and more

    Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application ...
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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 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 finalizes feedback processes for combo products

    Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle.   In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPA...
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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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    Advanced therapies: Navigation and application of EU and US guidelines during product development

    Continued progression and understanding in the development of advanced therapies has led to a significant increase in the number of products and types of indication under investigation, particularly for treating serious and life-threatening conditions. Although the principle regulatory requirements and guidance, as issued for traditional biologic products, can be generally applied, advanced therapies require additional regulatory and strategic considerations because of the...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote 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...
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    Advanced therapies: ‘Trip hazards’ on the development pathway

    This article concerns the development of advanced therapies and the challenges and complexities of getting them through the developmental pathway, which the authors call “the trip.” The authors examine at strategic levels the importance of some of the fundamental building blocks for the development program and highlight some commonly encountered challenges (trip hazards) for cell and gene therapies and offer “bench-to-bedside” and chemistry, manufacturing, and controls (CM...
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    A mandatory dietary supplement registry: Transparency as ‘disinfectant’

    The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of th...
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    Product Hopping: E&C Hearing Addresses Restrictions to Generic Competition

    A subcommittee of the House Energy & Commerce Committee held a hearing on Thursday raising questions around some of the tactics pharmaceutical companies use to block competition, including the controversial use of product hopping. Product hopping, which involves companies reformulating drugs to restrict competition, can include many different types of reformulations, such as a change from a capsule to a tablet, a change in dosing or strength or a reformulation to an ext...
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    FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products

    A little more than a year after pushing back the date by which combination product companies must comply with certain postmarket safety reporting (PMSR) requirements, the US Food and Drug Administration (FDA) on Tuesday extended the compliance deadline again. The updated guidance explains how FDA does not intend to enforce 21 CFR 4.102(c) and (d) (constituent part-based PMSR requirements), 4.104(b)(1) and (b)(2) (submission process for constituent part-based Individual ...