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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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    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   In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how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 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 ...
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    Combo Product Reviews: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how sponsors can determine which type of premarket submission is appropriate. The 22-page draft, which implements a section of the 21 st Century Cures Act , explains what combination products are, how their various FDA center assignments are determined and considerations for making approval pathway de...
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    FDA Officials Discuss Modernizing the Regulation of Combo Products

    As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature . Nina Hunter, FDA’s associate director for science policy, and Rachel Sherman, F...
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    FDA Offers Final Guidance on CGMP Requirements for Combo Products

    The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013. The guidance addresses general considerations for CGMP requirements for these drug-drug, drug-device, drug-biologic or biologic-device combination products and the purpose and content of specific provisions from 21 CFR part 4 . The guidance also discus...
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    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
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    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
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    Three FDA Final Rules Slated for Release in May

    Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products. Device Trial Data The final rule on medical device clinical s...
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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
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    FDA Expresses Desire to Work With Industry on CGMPs for Combo Products

    During RAPS’ and the Combination Products Coalition’s (CPC) recent workshop on current Good Manufacturing Practice (CGMP) for combination products, which took place on 1 April, the US Food and Drug Administration’s (FDA) lead presenter, John Barlow “Barr” Weiner, paused briefly to acknowledge the date’s popular connotation. “I just realized I should’ve inserted some sort of April fools [joke] in this presentation,” said Weiner, who is the associate director for polic...