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The US Food and Drug Administration (Rockville, MD) seeks volunteers to take part in a pilot project to test a Health Level 7 (HL7) data-interchange standard for submitting product stability data.
The US Food and Drug Administration (Rockville, MD, www.fda.gov) seeksvolunteers to take part in a pilot project to test a Health Level 7(HL7) data-interchange standard for submitting product stability data.The agency aims to improve the data-submission process by establishinga uniform, consistent procedure for preparing and presenting thisinformation for review.
FDA is currently considering adopting the Stability Data Standardalready adopted by HL7 (an international standards developmentorganization) and the American National Standards Institute. Ifadopted, the voluntary standard would apply to stability data in newdrug applications, abbreviated new drug applications, andinvestigational new drug applications.
The purpose of the pilot project is to assist in the evaluation of thedata interchange standard; provide data for testing the analyticaltools designed to facilitate the review of product stability data; andobtain feedback from reviewers and pharmaceutical companies on thecreation and use of standardized product-stability data.
A limited number of participants will be selected to submit data fortesting and provide technical feedback. Requests to participate may bemailed to: Division of Dockets Management (HFA-305), Food and DrugAdministration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.Electronic requests can be submitted to http://www.fda.gov/dockets/ecomments.For more information, contact Norman Schmuff at[email protected]
Deadline for all requests to participate is July 17, 2006.