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    PDUFA VII commitment letter: RWE, rare diseases see renewed attention

    The US Food and Drug Administration (FDA) on Monday released the commitment letter outlining performance goals and procedures for the upcoming reauthorization of the Prescription Drug User Fee Amendments for FYs 2023-2027 (PDUFA VII).   The agency also announced a public meeting on the reauthorization, scheduled for the afternoon of 28 September. Registration for the meeting, which will be held virtually, is free.   Many of the concepts and programs the agency di...
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    EMA adopts guideline on quality documentation for drug-device combination products

    The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).   It also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body. The MDR regulation went into effect in May 2021. (RELATED: EMA Kicks...
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    FDA issues draft guidance for transdermal adhesion systems

    The US Food and Drug Administration has issued new draft guidance for clinical trials examining the adhesion performance of transdermal and topical delivery systems (collectively, TDS) for new drug applications.   Surface area is an important variable in determining the amount of drug delivered through a TDS; adhesion performance can affect both safety and effectiveness of TDS products because adhesion failures can result in reduced effectiveness caused by suboptimal d...
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    Author offers advice for navigating combination products approval pathways

    With few comprehensive resources available covering combination products, RAPS’ recently released book, International Combination Products , by Jocelyn Jennings, MS, RAC (US, Drugs, Devices), fills a significant need for practical guidance on navigating the regulatory pathways for products combining multiple technologies. Prior to writing the book, “there was no place that I found that I could look to find all of the information I was interested in on different topics t...
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    Euro Convergence: Mind the gap in MDR's treatment of combo products

    Navigating the re-consultation process for drug-device combination products under EU’s new Medical Device Regulation can be tricky business, said panelists during a session at Euro Convergence 2021.   Speakers at the combination products-focused session shared experiences and highlighted gaps where manufacturers still need clarity from competent authorities, who themselves are feeling the strain of implementing new regulations while they continue to sort out post-Brexi...
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    Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...
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    Combination products: FDA releases PDUFA VI program report

    A new independent report on the US Food and Drug Administration’s (FDA) review practices for combination products under the Prescription Drug User Fee Act (PDUFA VI) gives the agency generally positive marks but finds room for refinements in communication and technology to improve the pre-submission and review process.   The report , commissioned by FDA as part of its PDUFA VI commitments, was conducted by Eastern Research Group and looked at FDA staff and sponsor e...
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    FDA releases compliance program for CDER, CDRH-led combination product inspections

    In a newly issued compliance program , the US Food and Drug Administration (FDA) explains its approach to inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products.   The 46-page document lays out FDA’s intended implementation of the compliance program; inspectional operations and reporting considerations; sampling and analytical testing expectations; regulatory and administrative stra...
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    FDA abandons proposal for devices referencing drugs

    The US Food and Drug Administration (FDA) on Thursday said it will abandon a proposed regulatory approach for medical devices referencing drugs (DRDs) that would have allowed devices to be authorized for new uses with already approved drugs when the drugmaker does not want to collaborate on the new use.   The decision comes after FDA held a public hearing to discuss the scientific, regulatory and legal challenges posed by the approach in November 2017. At the time, FDA...
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    FDA drafts guidance on emergency-use injector reliability

    The US Food and Drug Administration (FDA) this week issued draft guidance explaining how combination product developers can demonstrate that their emergency-use injectors will reliably deliver drugs as intended in a life-threatening emergency.   The guidance specifically applies to emergency-use injectors that are prefilled or co-packaged with emergency drugs or biologics, such as those to treat anaphylaxis, and is intended to expand on FDA’s 2013 guidance Technical ...
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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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    Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways

    The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products. Specifically, DRDs are medical devices that reference an already-marketed drug when the drugmaker does not want to work with the device sponsor to pursue the new use. FDA says it sees three situations where DRDs could be proposed: ...