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New FDA Guidance

FDA

The US Food and Drug Administration (Rockville,MD,www. fda.gov) released a new guidance covering the content of electronic common technical document (eCTD) submissions. The new Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, updates the Aug. 2003 draft guidance on the same topic.

The new guidance provides more specificity than earlier guidances regarding the organization of electronic submissions, and ...

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