United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-08-14 article Proposed Rules D09002ee1c7fc98e7 D09002ee1c7fc9961 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing a meeting entitled "Regulatory New Drug Review: Solutions for Study Data Exchange Standards" 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 below. 77 FR 48491 https://www.govinfo.gov/app/details/FR-2012-08-14/2012-19748 2012-19748 fr14au12-23 4160-01-P Docket No. FDA-2012-N-0780 https://www.govinfo.gov/app/details/FR-2012-08-14/2012-19748 https://www.govinfo.gov/content/pkg/FR-2012-08-14/html/2012-19748.htm https://www.govinfo.gov/content/pkg/FR-2012-08-14/pdf/2012-19748.pdf 2 p. 48491 48492 77 FR 48491 Title 21 Chapter 21 CFR Chapter Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting; Request for Comments; Federal Register Vol. 77, Issue PRORULE 2012-19748 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-11-05 Docket No. FDA-2012-N-0780 4160-01-P 2012-19748 Announcement of meeting, request for comments.

The Food and Drug Administration (FDA) is announcing a meeting entitled "Regulatory New Drug Review: Solutions for Study Data Exchange Standards" 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 below.

The meeting will be held on November 5, 2012, from 10 a.m. to 4 p.m. Ron Fitzmartin, Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 1160, Silver Spring, MD 20993, 301-796-5333, FAX: 301-847-8443, email: CDERDataStandards@hhs.fda.gov. Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Meeting; Request for Comments , CDERDataStandards@hhs.fda.gov http://www.cdisc.org http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.hl7.org http://www.regulations.gov Vol. 77, no. 157 Office of the Federal Register, National Archives and Records Administration 2012-08-14 continuing daily deposited born digital 443 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-08-14 P0b002ee1833d57aa 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14au12 https://www.govinfo.gov/app/details/FR-2012-08-14 https://www.govinfo.gov/content/pkg/FR-2012-08-14/pdf/FR-2012-08-14.pdf https://www.govinfo.gov/content/pkg/FR-2012-08-14/xml/FR-2012-08-14.xml fdlp 48419 48853 DGPO 2012-08-14 2024-06-03 FR-2012-08-14 machine generated eng FR FR-2012-08-14 77 157