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Guidance Documents/Guidance-Document/Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 18, 2014

April 14, 2020

Center for Drug Evaluation and Research

e05964dd-2751-4636-8630-94e3ed036135

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