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FDA Global Pharma Safety Plan Looks To Food Model

This article was originally published in The Tan Sheet

Executive Summary

FDA seeks new authority over the international drug supply chain to support a global safety plan.

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

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.

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

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.

IOM Pushes For FDA Collaboration With Foreign Regulators

In a report on how FDA, industry and other stakeholders can strengthen food and drug regulatory systems abroad, the Institute of Medicine recommends the agency provide incentives for foreign regulators to meet U.S. standards and facilitate training and for the government to help hold importers liable.

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