FDA to be Affected by shutdown

miamianne67
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FDA to be Affected by shutdown Jan 10, 2019 13:10:29 GMT via mobile

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Post by miamianne67 on Jan 10, 2019 13:10:29 GMT

• In a tweet, FDA Commissioner Scott Gottlieb, M.D. says the agency is having to shift resources from premarket drug review work to safety surveillance during the federal government shutdown as President Trump and congressional leaders squabble over the border wall. Drug firms will, no doubt, notify their lobbyists on this development.

icemandios
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FDA to be Affected by shutdown Jan 15, 2019 16:16:47 GMT stcks and sgard434 like this

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Post by icemandios on Jan 15, 2019 16:16:47 GMT

Maybe not all of the FDA is affected by the shutdown.

Case in point:

Prior to the shutdown, TRXC received a 510(k) Clearance for the 3mm Senhance instruments in just over 4 months. Applied 6/7/18 and cleared on 10/11/18.

With the shutdown in week 3 (or is it 4?), TRXC received 510(k) Clearance for the Senhance Ultrasonic system on 1/15/19. They applied on 9/6/18. Just over 4 months.

stcks Eternal 6 rules of successful biotech investing-"RESEARCH, RESEARCH, RESEARCH, PATIENCE, CAPITAL & RESEARCH" Posts: 3,850 OPKO Investment: Long Sentiment: Bullish Recommendation: Hold Sept 30, 2015 15:29:56 GMT	FDA to be Affected by shutdown Jan 15, 2019 16:23:59 GMT via Tapatalk sgard434 and icemandios like this Quote Select Post Deselect Post Link to Post Member Give Gift Back to Top Post by stcks on Jan 15, 2019 16:23:59 GMT And that was with Thanksgiving, Christmas and New Year's and the two days before and after everyone takes off. Edited: last Monday was a snow day! No one worked
	Last Edit: Jan 16, 2019 14:19:26 GMT by stcks 6 rules of successful biotech investing-"RESEARCH, RESEARCH, RESEARCH, PATIENCE, CAPITAL & RESEARCH"

icemandios OpkoDD Moderator [TI0] Posts: 16,762 Member is Online Sept 30, 2015 17:37:42 GMT	FDA to be Affected by shutdown Jan 16, 2019 14:17:01 GMT Quote Select Post Deselect Post Link to Post Member Give Gift Back to Top Post by icemandios on Jan 16, 2019 14:17:01 GMT OTOH, looks like if one waited to the last minute to pay the user fee, the shutdown comes into play: www.biopharmadive.com/news/aimmune-ar101-fda-review-hold-government-shutdown/546016/

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Post by miamianne67 on Jan 10, 2019 13:10:29 GMT

Post by icemandios on Jan 15, 2019 16:16:47 GMT

Post by stcks on Jan 15, 2019 16:23:59 GMT

Post by icemandios on Jan 16, 2019 14:17:01 GMT

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