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  • 1.  Regulatory Focus News & Articles- US Government Shutdown and the FDA

    Posted 08-Jan-2019 12:29

    Hi RegEx Members,

    One of our biggest goals here on RegEx is to keep up-to-date on member's interests and hot topics in the regulatory field. Recently, we've noticed that the partial US government shutdown and its impact on the FDA has been a trending discussion in the community. We wanted to provide you with some Regulatory Focus News & Articles, that we hope you find useful.

    FDA Has About One Month of User Feed Funds Left, Gottlieb Warns

    UPDATE: Government Shutdown Continues as Gottlieb Clarifies FDA's Activities

    Feel free to add your own articles and relevant content to this discussion thread.

    Best,

    Emily



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    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
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  • 2.  RE: Regulatory Focus News & Articles- US Government Shutdown and the FDA

    Posted 09-Jan-2019 10:49
    Edited by April Corella 09-Jan-2019 10:49
    Thank you for the post. Very interesting. Companies will need to plan for possible delays regarding new submissions.

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    April Corella
    Temecula CA
    United States
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    Original Message


  • 3.  RE: Regulatory Focus News & Articles- US Government Shutdown and the FDA

    Posted 10-Jan-2019 10:09
    <g class="gr_ gr_11 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="11" data-gr-id="11">Thanks</g> Emily for establishing this timely thread.

    For my part, Scott Gottlieb's Twitter Feed has been the most timely source of updates:

    https://twitter.com/SGottliebFDA

    Regarding pre-market development activities Washing Times has one recent blurb on the topic:

    https://www.washingtontimes.com/news/2019/jan/9/fda-shifting-funds-drug-safety-amid-government-shu/

    The FDA's internal guidance has been somewhat helpful:

    https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629208.htm
    https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629114.htm
    https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629207.htm

    I have received the FDA's standard shutdown email as a bounce back a couple times, but for the most <g class="gr_ gr_420 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="420" data-gr-id="420">part</g> the RPMs I correspond with are in the office.  Would be happy to hear others experience. Also if anyone has <g class="gr_ gr_482 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="482" data-gr-id="482">list</g> from OPM of FDA divisions/offices etc or even <g class="gr_ gr_550 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="550" data-gr-id="550">fda</g> employees that are furloughed that would be appreciated. 






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    Matt Medlin RAC
    Manager, US Regulaotry Affairs R&D Pipeline
    Durham NC
    United States
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    Original Message


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