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The C.D.C. is working with the food and drug agency and with test manufacturers to gather, analyze and coordinate the submission of data for federal approval of NAATs for use in the throat and rectum.
(2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization?
"At this point, our plan is to work cooperatively with the F.D.A. on this application and to actively and aggressively pursue the accumulation of data and the acquisition of data and the submission of data for the cohesive gel product," Mr. Teti said.
As also unpredicted effects must be explored the submission of data is not bound to risk hypotheses.
Encourage the submission of data corrections and ensure that these feed into future releases of the data.
However, the submission of data from EpiCollect to a central database relies on connectivity with mobile data networks.
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We expect the DDBJ Pipeline to analyse users' NGS data, thereby accelerating the submission of NGS data to public databases such as DDBJ.
Although both the EPA and the FDA have discussed possible uses of microarray data, only the FDA has issued requirements for the submission of such data.
Similarly, we, the members of the Microarray Gene Expression Data (MGED Societyy (http://www.mged.org), believe that all scholarly scientific journals should now require the submission of microarray data to public repositories as part of the process of publication.
http://www.mged.org/ Guidance for Industry: Pharmacogenomic Data Submission This guidance, issued by the FDA in draft form in November 2003, contains nonbinding recommendations on the submission of pharmacogenomics data during the drug application process.
The raw data were not in the possession of the U.S. EPA, and the U.S. EPA could not compel the submission of these data from Harvard University or the funding source, the American Cancer Society.
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