Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting; Request for Comments



02-Oct-12

The Food and Drug Administration (FDA) is announcing a meeting entitled “Regulatory New Drug Review: Solutions for Study Data Exchange Standards” on 5th November 2012, the purpose of which is to solicit input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. FDA also seeks input from stakeholders and other members of the public on this topic and a set of premeeting questions discussed in the link below.

https://www.federalregister.gov/articles/2012/08/14/2012-19748/regulatory-new-drug-review-solutions-for-study-data-exchange-standards-notice-of-meeting-request-for



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