Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Annual Reports for New Drug Applications and Abbreviated New Drug Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format-- Annual Reports for NDAs and ANDAs." This draft guidance is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. The draft guidance discusses issues related to the electronic submission of annual reports for approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) to FDA's Center for Drug Evaluation and Research (CDER). It is expected that the submission of these reports in electronic format will improve the agency's efficiency in processing, archiving, and reviewing the reports.