FDA, CDER Data Standards Plan

The FDA is announcing the availability for public comment of the draft
document entitled "CDER Data Standards Plan Version 1.0". The draft plan
outlines the general approach proposed for development of a comprehensive
data standards program in the Center for Drug Evaluation and Research
(CDER). The draft plan identifies key objectives for a data standards
program at CDER, processes to be developed to ensure successful use of those
standardized data, and a set of recommended projects beginning this calendar
year [1, 2].

Please let me know if you would be interested in contributing to
HCLS reviewing the plan and providing feedback.

Cheers,

Susie



1. *Federal Register*, 17 June 2010, *75*(116), 34452-34453,
http://edocket.access.gpo.gov/2010/pdf/2010-14637.pdf<http://cbn.eu.jnj.com/cbn/newsreading/readnews/readsummary.jsp?url=http%3A%2F%2Fedocket.access.gpo.gov%2F2010%2Fpdf%2F2010-14637.pdf&articleId=175127>

2. FDA, CDER Data Standards Plan (Version 1.0), Posted online 17 June 2010,
www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf<http://cbn.eu.jnj.com/cbn/newsreading/readnews/readsummary.jsp?url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FDrugs%2FDevelopmentApprovalProcess%2FFormsSubmissionRequirements%2FElectronicSubmissions%2FUCM214120.pdf&articleId=175127>