Zdrowie i gospodarka · 28/08/2003

FDA Releases Draft Guidance on Electronic Submission of Annual Reports for New Drug Applications and Abbreviated New Drug Applications

The Food and Drug Administration (FDA) has made available a draft guidance document outlining the agency's expectations for submitting annual reports for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in electronic format, with the goal of increasing efficiency in processing and reviewing these reports.