Electronic Submissions - The Requirement for Standardized ...
Electronic Submissions - The Requirement for Standardized Study Data Mary Ann Slack Deputy Director, Office of Strategic Programs. Ron Fitzmartin, PhD, MBA
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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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Study Data Specifications - Food and Drug …
www.fda.govStudy Data Specifications STUDY DATA SPECIFICATIONS . These specifications are for submitting animal and human study datasets in electronic format.
Sanofi Pasteur 20 April 2016v0.2 095 - ActHIB LE6940
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Repackaging of Certain Human Drug Products by …
www.fda.govRepackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. Guidance for Industry . Additional copies are available from: Office of …
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