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FDA Draft Guidance on Providing Regulatory Submissions in Electronic Format - PharmaFacts
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FDA Draft Guidance on Providing Regulatory Submissions in Electronic Format

Federal Register, Vol. 79, No. 25: Providing Regulatory Submissions in Electronic Format—

Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act:

http://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02553.pdf

The Draft Guidance:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384686.pdf