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GUIDANCE DOCUMENT

Providing Submissions in Electronic Format — Postmarketing Safety Reports June 2014

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2001-D-0067
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This is one in a series of guidance documents intended to assist applicants making certain regulatory submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or the Agency). This draft guidance revises and replaces the draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports, issued on June 12, 2008 (73 FR 33436).

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0067.

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