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Guidance for Industry - Food and Drug …
Guidance for Industry Q3A Impurities in New Drug Substances Additional copies are available from: Office of Training and Communication Division of Drug Information
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eSubmitter Quick Guide - Food and Drug …
www.fda.govAllows you to create a new submission entry. The New Submission Data Dialog box will ap-pear. See section Creating a New Submission for more detailed information.
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www.fda.govStudy Data Specifications STUDY DATA SPECIFICATIONS . These specifications are for submitting animal and human study datasets in electronic format.
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