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Home > New FDA Approvals > 037 - GenePOC C. Diff test approved by FDA; GSK seeks FDA approval of single-dose tafenoquine to treat P. vivax malaria; FDA issues two guidances on CLIA waiver applications, 510(k) dual submissions


	Podcast:		New FDA Approvals
	Episode:		037 - GenePOC C. Diff test approved by FDA; GSK seeks FDA approval of single-dose tafenoquine to treat P. vivax malaria; FDA issues two guidances on CLIA waiver applications, 510(k) dual submissions
	Category:		Science & Medicine
	Duration:		00:08:06
	Publish Date:		2017-11-29 07:00:00
	Description:		November 29, 2017 0:30 GenePOC C. Diff Test Approved by FDA http://www.genepoc-diagnostics.com/wp-content/uploads/2017/11/PR-GenePOC-CDiff_510k_20171122-EN_Final.pdf 2:19 Malaria drug: GSK seeks FDA approval of single-dose tafenoquine to treat Plasmodium vivax malaria https://www.gsk.com/en-gb/media/press-releases/gsk-submits-us-regulatory-application-for-single-dose-tafenoquine-for-plasmodium-vivax-malaria/ 4:30 FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions http://www.raps.org/Regulatory-Focus/News/2017/11/28/28937/FDA-Issues-Two-Guidances-on-CLIA-Waiver-Applications-510k-Dual-Submissions/ https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM586502.pdf If we can help with any medical writing, please reach out to us at info@nascentmc.com Our US-based company, Nascent Medical, LLC, has a team of over 100 PhD-/MD-level writers who can write about any medical, scientific or technical topic. We charge a flat rate and provide an upfront estimate. Our turn around times can be as short as 1 to 2 days depending on the length of the project, and we don't charge extra for our speediness. Have you updated your blog or posted any press releases lately? That's a small project that some clients like to test us out with to start. We do the following types of writing, including but not limited to: -Video and virtual reality script writing -eLearning scripts -Medical education -Webinar slide creation -Manuscripts -Slidesets -Manuscripts -Press releases -Blog posts -Annual reports -Proposals -White papers -Web content -Posters -Sales training materials ------ Please contact info@scimedly.com for data analysis and visualization in the biomedical sciences.
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