# Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
> **Food and Drug Administration** · Final rule. · Published 2014-06-10 · Effective 2015-06-10 · 79 FR 33072
## Document
- **Document number:** 2014-13480
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 33072
- **CFR reference:** 21 CFR 310
- **Publication date:** 2014-06-10
- **Effective date:** 2015-06-10
- **HHS docket:** Docket No. FDA-2008-N-0334
## Abstract

The Food and Drug Administration (FDA or we) is amending 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. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/06/10/2014-13480/postmarketing-safety-reports-for-human-drug-and-biological-products-electronic-submission)
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