Zdrowie i gospodarka · 24/06/2003

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Periodic Adverse Drug Experience Reports; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports." This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This specific guidance discusses issues related to the electronic submission of postmarketing periodic adverse drug experience reports for drug products marketed for human use with new drug applications (NDAs) and abbreviated new drug applications (ANDAs), and therapeutic and blood products marketed for human use with biologics license applications (BLAs). This guidance does not apply to vaccines, whole blood or components of whole blood. The submission of these reports in electronic format will significantly improve the agency's efficiency in processing, archiving, and reviewing the reports.