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ready CDER Data Standards Plan Version 1.0

General Information

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.

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Standards and Databases mentioned in this policy


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