Issue Date: August 18, 2015
Issued by: Center for Biologics Evaluation and Research
Topic(s): Postmarket, Electronic Submissions, Safety – Issues, Errors, and Problems, Vaccines
Status: Final
Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines: Guidance for Industry
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.
Download the Guidance Document
