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REGULATORY DEVELOPMENTS

BY ALM Staff
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

The FDA proposes amending current regulations that outline the duty of members of the industry to report safety information their products to the agency. See, 'FDA Announces Proposed Rule to Improve Safety Reporting for Human Drugs and Biological Products' (available at www.fda.gov/oc/initiatives/barcode-sadr/fs-sadr.html). As described in this press release, among its many features, the proposed rule requires:

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