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FDA Toots Its Own Horn On Safety Of Marketed Drugs, Imports

This article was originally published in The Tan Sheet

Executive Summary

FDA’s Global Engagement report describes the agency’s actions to protect the international supply chain. Meanwhile, the Advances in FDA’s Safety Program for Marketed Drugs report notes label changes and safety studies mandated under its post-market drug safety program.

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Extra-Label Communication Could Foster Novel Switch NDAs – Industry Attorney

FDA has several avenues to foster more novel Rx-to-OTC switches, including allowing extra-label communications beyond the packaging, similar to dispensing labeling used by a pharmacist, to be part of an approval.

Extra-Label Communication Could Foster Novel Switch NDAs – Industry Attorney

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