Combo Products Guidance Could Help Point Novel OTC Switches In Right Direction
This article was originally published in The Tan Sheet
FDA delivers a draft GMPs guidance for combination products, providing details and examples on how the agency regulates drug delivery devices and other drug/device products. The document could be useful for firms interested in proposing novel Rx-to-OTC switches.
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FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. An industry coalition says key details need to be filled in by FDA with guidance.
FDA official Rikin Mehta assures stakeholders that the proposed new paradigm for Rx-to-OTC switches would not create a third class of drugs, give pharmacists prescribing power or eliminate the need for consumers to visit doctors.
A novel switch application comprising a drug and a device would be “a classic combination product” and FDA has a framework for evaluation, says Bradley Merrill Thompson, an attorney who focuses on medical device law.