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Entreprise · 08/09/20141 min de lecture
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →