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GUIDANCE DOCUMENT

E2E Pharmacovigilance Planning April 2005

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2004-D-0245
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this guidance, the term drug denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this guidance is on a safety specification and pharmacovigilance plan that might be submitted at the time of license application. The guidance can be used by sponsors to develop a stand-alone document for regions that prefer this approach or to provide guidance on incorporation of elements of the safety specification and pharmacovigilance plan into the Common Technical Document (CTD).

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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-2004-D-0245.

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