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GUIDANCE DOCUMENT

Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines Guidance for Industry August 2015

Final
Docket Number:
FDA-2014-D-0903
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This is one in a series of guidance documents intended to assist you, an applicant, in making postmarket regulatory submissions in electronic format to the Center for Biologics Evaluation and Research (CBER) at FDA. The guidance provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products, including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), 1 into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program established in response to the National Childhood
Vaccine Injury Act2 of 1986, which requires health professionals and vaccine manufacturers to report specific adverse events that occur after the administration of routinely recommended vaccines. VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. The guidance is applicable to vaccine products marketed for human use with approved biologics license applications (BLAs) for which CBER has regulatory responsibility. The guidance does not apply to any other biologic product. 


Submit Comments

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-2014-D-0903.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010