Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
other · Food and Drug Administration · Rule · Published 2014-09-08 · Effective 2014-09-08 · 79 FR 53133
Document
Document number
2014-21266
Federal Register citation
79 FR 53133
CFR reference
21 CFR 310
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-09-08
Effective date
2014-09-08
HHS docket
Docket No. FDA-2008-N-0334
Abstract
The Food and Drug Administration (FDA) is correcting a final rule entitled "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements" that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's 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. The document was published with an incorrect RIN number. This document corrects the error.