U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Providing Submissions in Electronic Format — Postmarketing Safety Reports
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Providing Submissions in Electronic Format — Postmarketing Safety Reports June 2014

Draft

Not for implementation. Contains non-binding recommendations.

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 This draft guidance revises and replaces the draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports, issued on June 12, 2008 (73 FR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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.