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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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 This draft guidance revises and replaces the draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports, issued on June 12, 2008 (73 FR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).
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:
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.