CDER Data Standards Plan Version 1.0
Homepage https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/cder-data-standards-program
Countries that developed this resource United Kingdom
Published in 2010
Type: Funder
Description:
CDER is responsible for ensuring that prescription, generic, and over-the-counter (OTC) drug products are safe, effective, and adequately available to the public.The objectives of the data standards plan are to establish a comprehensive data standards program at CDER, ensure development of data standards for all key data needed to make regulatory decisions, and ensure successful use of those standardized data.Taxonomic range
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How to cite this record FAIRsharing.org: CDER Data Standards Plan Version 1.0; DOI: https://doi.org/10.25504/FAIRsharing.p2vx5e; Last edited: Nov. 11, 2019, 3:34 p.m.; Last accessed: Feb 26 2021 9:41 a.m.
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United States Department of Health and Human Services (Government body)
United States Food and Drug Administration (FDA) (Government body)
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FAQ | https://www.fda.gov/AboutFDA/CentersOffi ... |
contact form | http://www.accessdata.fda.gov/scripts/em ... |
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Contact | General Contact |