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The RFD Process: Time for Reform?
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The RFD Process: Time for Reform?
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs —The Federal Food, Drug, and Cosmetic Act (FD&C Act) has very different regulatory regimes for pharmaceutical products than devices. Knowing how a product will be regulated is essential to companies. The means to gaining that knowledge for combination products or single entity products where the regulatory classification is unclear is the Request for Designation (RFD). A…
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