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Providing Regulatory Submissions in Electronic Format - General Considerations
Internet:http://www.fda.gov/cder/guidance/2867fnl.pdf
Origin/Publisher:Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/cder/guidance/index.htm
Content:This guidance is intended to provide assistance to making regulatory submissions in electronic format to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, FDA.
Document Type:FDA Guidance for Industry