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Drug & Device News

By ALM Staff | Law Journal Newsletters |

Early Public Disclosure of Suspected Drug Safety
Issues Begins

In September, the U.S. Food and Drug Administration (FDA) published the first of its planned quarterly reports listing the drugs that are under evaluation by the agency for potential safety problems. The new reporting system was imposed on the FDA by legislation signed into law a year ago as part of the Food and Drug Administration Amendments Act of 2007. Under the law, the FDA is required to inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in the FDA's Adverse Event Reporting System (AERS).

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