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  • Regulatory NewsRegulatory News

    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    The US Food and Drug Administration (FDA) this week issued draft guidance explaining how combination product developers can demonstrate that their emergency-use injectors will reliably deliver drugs as intended in a life-threatening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    The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how sponsors can determine which type of premarket submission is appropriate.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: ...
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    FDA Finalizes Combination Product Classification Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices. The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act , and details how F...
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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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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...
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    Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council

    Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements. J&J calls on FDA’s new council to address the process and principles for determining the primary mode of action with cross-center collaboration to ensure technical considerations are included in the dec...
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    Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Offers Fast-Track Approvals to HIV, Hepatitis Combination Products The Drug Controller General of India (DCGI) is offering fast-track approvals to combination products to treat HIV and hepatitis B and C. DCGI Dr GN Singh is prepared to waive the need to run clinical trials and truncate the regulatory submission process to cut the time it takes for sponsors to br...
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    EMA Weighs New Guideline on Quality Requirements for Combination Products

    The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stan...
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    FDA Details Combination Product Postmarket Safety Reporting Requirements

    The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting. In a webcast last week, John Weiner, associate director for policy at the Office of Combination Products (OCP), explained which parts of the rule manufacturers should be following now, and which will they will be required to comply with beginning July 2017. Weiner ...