CDER Data Standards Plan Version 1.0
Countries that developed this resource United Kingdom
Published in 2010
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.
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: Jun 06 2020 2:08 a.m.
Edits to 'https://fairsharing.org/FAIRsharing.p2vx5e' by 'The FAIRsharing Team' at 15:34, 11 Nov 2019 (not approved): 'homepage' has been modified: Before: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf After: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/cder-data-standards-program
Edits to 'https://fairsharing.org/FAIRsharing.p2vx5e' by 'The FAIRsharing Team' at 23:13, 20 Feb 2017 (approved): 'contact' has been modified: Before: After: General Contact Organisations have changed: Previous values: Center for Drug Evaluation and Research|USA New values: Center for Drug Evaluation and Research|USA US Food and Drug Administration US Department of Health and Human Services Support links have changed: Previous values: New values: http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/FAQsaboutCDER/default.htm Domain list has changed: Previous values: Data sharing|| Metadata standards|| New values: Data sharing|| Metadata standards|| Life Science|domain| Biomedical Science|None| Drug|material|http://purl.obolibrary.org/obo/CHEBI_23888
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United States Department of Health and Human Services (Government body)
United States Food and Drug Administration (FDA) (Government body)
TOP Level Data Transparency: Link Broken
TOP qualifying comments: Link Broken
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