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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.
What you need to know about the House and Senate’s user fee reauthorization bills
AgencyIQ’s team of regulatory policy experts will unpack and analyze the House and Senate’s user fee reauthorization and FDA reform bills, what they would do, what they would mean for different life sciences sectors, and how things may evolve in the coming weeks and months.
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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