Policies > DOI:10.25504/FAIRsharing.p2vx5e

ready CDER Data Standards Plan Version 1.0

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Homepage http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf

Developed in United Kingdom

Published in 2010

Type: Funder


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.

How to cite this record: FAIRsharing.org: CDER Data Standards Plan Version 1.0; DOI: https://doi.org/10.25504/FAIRsharing.p2vx5e; Last edited: Feb. 22, 2018, 3:07 p.m.; Last accessed: Mar 20 2018 2:20 a.m.

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