Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Providing Regulatory Submissions in Electronic Format - Postmarketing Periodic Adverse Drug Experience Reports
Internet:	http://www.fda.gov/cder/guidance/4153dft.pdf
Origin/Publisher:	Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/cder/guidance/index.htm
Content:	Providing Regulatory Submissions in Electronic Format - Postmarketing Periodic Adverse Drug Experience Reports
Document Type:	FDA Document