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Summary: Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements (Final Rule)

The Food and Drug Administration amends its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports.

Regulatory Impact Analysis

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements (Final Rule) (PDF - 460 KB)

Federal Register:  79 FR 33072 -33092, June 10, 2014

Docket: FDA-2008-N-0334