#FDA PRODUCT BUILDER SOFTWARE#
#FDA PRODUCT BUILDER CODE#

The device labeling on this website may not be the labeling on currently distributed products. The device labeling has been reformatted to make it easier to read but its content has not been altered nor verified by FDA. FDA has not reviewed this information prior to posting on this website. The device labeling and other device-specific information on this website have been voluntarily submitted to the FDA by device manufacturers. In addition, FDA is not aware of scientific evidence to support homeopathy as effective. Drugs marked 'unapproved medical gas', 'unapproved homeopathic' or 'unapproved drug other' on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. Drugs marked 'OTC monograph final' or 'OTC monograph not final' are not checked for conformance to the monograph. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. (See 21 CFR part 207.) The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). The Sentinel Summary Tables v2 Investigator Release Notes describe changes in version 2 of the Summary Tables SAS Package.Please be aware of the following when using information from this Web site: Read more about Summary Tables SAS Package Summary Tables Programming Package V2 Investigator Release Notes

#FDA PRODUCT BUILDER CODE#

This package includes all SAS code and lookup/reference tables used. The Summary Tables SAS Packages includes the complete SAS program package distributed to Sentinel Data Partners to create the summary tables from their Sentinel Common Data Model compliant datasets. Read more about Technical Discussion of Summary Table V2 Package (v0.3) Summary Tables SAS Package The Technical Discussion of Summary Table v2.0 Package describes the various technical approaches and methods that guided the design and development efforts for the v2.0 Summary Tables Package. Read more about Summary Table V2 Programming Specifications (v1.0) Technical Discussion of Summary Table V2 Package (v0.3) The Sentinel Summary Table V2 Programming Specifications describe the logic and processes required to create summary tables for the Sentinel Query Tool. Read more about Distributed Query Tool Summary Table Descriptions v2.0 Summary Table V2 Programming Specifications (v1.0) The Sentinel Query Tool Summary Table Description delineates the structure of the summary tables that were previously supported by the query tool. Read more about Sentinel Distributed Query Tool / PopMedNet Documentationĭistributed Query Tool Summary Table Descriptions (v2.0) The Sentinel Distributed Query Tool implementation is compliant with Federal Information Security Management Act (FISMA) Moderate level as defined by NIST SP 800-53 Revision 4, Recommended Security Controls for Federal Information Systems.

#FDA PRODUCT BUILDER SOFTWARE#

The PopMedNet software facilitates secure distribution and response of all Sentinel distributed queries. Sentinel uses PopMedNet, an open-source software application, to enable the operation and governance of the secure Sentinel distributed data network.

Fda product builder