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Combo Products Guidance Could Help Point Novel OTC Switches In Right Direction

This article was originally published in The Tan Sheet

Executive Summary

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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Industry Seeks More Clarity Following Combo Product GMP Final Rule

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 Aims To “NSURE” Clarity About New Paradigm For OTC Switches

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.

Combination Products Offer Regulatory Option For Novel Switches

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