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FDA publishes guidance on its drug importation final rule

This week the FDA issued final guidance on the importation of prescription drugs final rule to help small entities better under the regulatory requirements. The guidance is intended to serve as a companion guide and streamline some of the key information in the final rule.

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FDA releases 24 new, 14 revised product-specific guidances

Several new and revised product-specific guidance documents published this week by the FDA’s Office of Generic Drugs provide recommendations for the development of various generic drug products, including several complex generics.

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