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  • == FDA/PhUSE Annual Computational Science Symposium, Washington (March 19-20, 2012
    4 KB (597 words) - 13:50, 10 December 2011
  • **FDA Working Groups (need a main page for the working groups)
    5 KB (748 words) - 03:52, 2 May 2012
  • ...nt the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not [[Category:FDA Working Groups]]
    8 KB (1,192 words) - 08:24, 24 July 2020
  • **Awaiting feedback from FDA for 'What does the FDA do' **FDA are going to start working on Define in November which may take around two
    2 KB (342 words) - 10:50, 15 October 2018
  • *We presented at the PhUSE FDA Quarterly Forum. See CPE page for presentation if interested. Asking for **AE white paper follow-up - consolidated terms (On hold - waiting to see if FDA and/or CIOMS makes progress)
    3 KB (429 words) - 11:36, 15 October 2018
  • FDA & PMDA require standardised study data for certain regulatory submissions. ...a.Baldwin@fda.hhs.gov|| Bhanu Kannan || Participant || FDA || Bhanu.Kannan@fda.hhs.gov
    7 KB (869 words) - 03:29, 20 July 2020
  • ==FDA Working Groups== #Add links to working group main pages to [[FDA Working Groups]]
    2 KB (267 words) - 16:11, 16 December 2011
  • =FDA Working Group Workflow=
    6 KB (1,059 words) - 09:55, 23 January 2012
  • :::define.xml resources, how to create, cdisc macros, links to FDA documentation
    2 KB (280 words) - 07:42, 22 March 2012
  • *Introduction and goals of the wiki specific to the FDA working groups
    892 bytes (139 words) - 04:19, 3 February 2012
  • * [[AddingFDAWGminutes |Adding minutes for FDA working groups by template]] This is a short video showing the process
    7 KB (1,259 words) - 06:27, 14 February 2012
  • ...tyle="text-align:center;">The PHUSE Wiki is an [http://www.phuse.eu PHUSE]/FDA/Industry collaboration to provide a medium to share information specificall [[Image:PHUSE-FDA_Challenge.jpg|500x500px|link=https://www.phuse.eu/phuse-fda-data-science-innovation-challenge]]<br>
    13 KB (1,837 words) - 09:49, 10 August 2020
  • According to the FDA "Guidance for Industry - Use of Histology in Biomarker Qualification Studie
    6 KB (701 words) - 10:44, 26 May 2017
  • **Positive feedback from FDA *FDA Questions
    4 KB (618 words) - 12:21, 21 April 2015
  • #Data available via FDA SBA’s may be used for evaluating use cases and developing data analysis m
    3 KB (438 words) - 13:47, 13 October 2015
  • '''Welcome to the FDA/PhUSE Computational Sciences Nonclinical Topics Working Group''' <br />
    352 bytes (52 words) - 09:13, 18 July 2016
  • * Discussed new process on FDA page where vendors and CROs can no longer do sample submissions. * FDA using Pinnacle21 community validator, same as publically available
    2 KB (371 words) - 10:10, 21 July 2016
  • ** FDA scripts: what from here?
    2 KB (319 words) - 08:17, 21 July 2016
  • This is a short video showing how to update the FDA working group minute templates [http://dl.dropbox.com/u/5406177/phuse-fda.ogv Adding FDA working Group minutes]
    251 bytes (39 words) - 11:19, 23 January 2012
  • New Minutes for FDA working Groups can be added using a template. This is slightly different fr
    1 KB (217 words) - 17:49, 25 January 2012

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