Zdrowie i gospodarka · 5.02.2004
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Content of Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Content of Labeling." This draft guidance is one in a series of guidance documents on providing regulatory submissions to the FDA in electronic format. In the Federal Register of December 11, 2003 (68 FR 69009), FDA published a final regulation (the electronic labeling rule) requiring that the content of labeling for marketing applications be submitted in electronic format in a form that FDA can process, review, and archive. The draft guidance provides information on submitting the content of labeling in electronic format for review with new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs).