Zdrowie i gospodarka · 16.05.2006
Product Stability Data; Notice of Pilot Project
The Food and Drug Administration (FDA) is seeking volunteers to participate in a pilot project involving the testing of a Health Level 7 (HL7) data interchange standard for the submission of product stability data to FDA to facilitate the review of this data. Using the data interchange standards and the analytical tools will allow consistent data presentation to the agency and allow a reviewer to more efficiently and consistently display and evaluate product stability data submitted in electronic format.