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REGULATORY DEVELOPMENTS

By ALM Staff | Law Journal Newsletters |
September 16, 2003

On March 13, 2003, Tommy G. Thompson, Secretary of the U.S. Department of Health and Human Services (HHS), announced two proposed rules from the Food and Drug Administration (FDA) that are intended to improve patient safety and are part of a strategic initiative by the FDA to reduce adverse events involving products that it regulates.

Proposed Rule: Safety Reporting Requirements for Human Drug and Biological Products

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