federal_register: 2012-28197

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-28197 Development of Prioritized Therapeutic Area Data Standards; Request for Comments Notice The Food and Drug Administration (FDA) is announcing the intent to prioritize and develop therapeutic area data standards to facilitate the conduct of clinical research and the regulatory review of medical products. Therapeutic area disease and domain specific data standards should enable and enhance the ability to integrate, analyze, report, and share regulatory information. FDA has developed a roadmap that provides its current thinking on therapeutic area priorities and has posted it on the FDA Web site. FDA is actively participating with regulated industry, the Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute, Health Level 7's (HL7) Clinical Interoperability Council, and other stakeholders to support the development of these therapeutic area standards. The therapeutic area standards will be developed collaboratively based on open, consensus- based data standards development methodology. 2012-11-20 2012 11 https://www.federalregister.gov/documents/2012/11/20/2012-28197/development-of-prioritized-therapeutic-area-data-standards-request-for-comments https://www.govinfo.gov/content/pkg/FR-2012-11-20/pdf/2012-28197.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the intent to prioritize and develop therapeutic area data standards to facilitate the conduct of clinical research and the regulatory review of medical products. Therapeutic area disease and domain...

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