FDA’s Combination Product Guidance Clarifies Common Questions
[Thursday, February 7, 2019] FDA recently provided useful tips to developers of combination products that confirms well-understood processes while also providing more details to aid strategic development. Combination products offer an attractive option to provide a wholesome standalone product with convenient and reliable outcomes such a prefilled-syringes that offer ease for administration or patches filled with drugs that offer slow release using physical principles rather than complicated slow-release formulations. However, since combo products contain distinctly regulated components, they raise unique questions about the regulatory pathways, processes to interact with FDA and time-lines. Since distinct components of a combination product are regulated by different departments within the FDA, theoretically it could require a developer to meet different and seemingly contradictory requirements located in multiple documents. However, over the last two decades, FDA has clarified several processes governing regulation and approval of combo products. The new guidance further emphasizes these older principles while providing a concise guidance connecting the various pieces. It describes the principle of assigning lead agency within FDA for each product via the primary mode of action and the request for designation processes. Then it describes the three potential pathways for combo products: those regulated primarily as a device, drug or biologic, with details of each pathway. For example, the guidance emphasizes that while most combination products designated as medical devices would require a PMA application, there are ways to request de novo 510k or even class I designation for such devices. Similarly, the device information can be included in the same NDA or BLA instead of filing a separate application for combination products designated a drug or biologic, respectively. While more experienced regulatory experts will not find much new in the new guidance document, it is an useful read for new developers and for educational purposes.
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