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).
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.