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FDA confidential information

This article was originally published in The Tan Sheet

Executive Summary

Agency says in a final rule published in the Nov. 19 Federal Register that FDA is allowed to disclose nonpublic safety, effectiveness or quality information about the products it regulates to foreign government officials. The final rule explicitly describes safeguards that apply to authorized disclosures of confidential information to foreign governments, including that the release of such information may require written authorization from the product's sponsor.
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