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How to Register a Hand Sanitizer Product in the US

How to Register a Hand Sanitizer Product in the US

Due to the COVID-19 pandemic, world-wide demand has soared for hand sanitizer and anti-viral products. Below, we outline five basic steps for domestic and foreign manufacturers or domestic distributors who want to get their drug product into the US market but never dealt with the FDA’s electronic drug registration and listing. The scope of products includes: Rx (Prescription Drugs) and OTC (Over the counter) – ex. Hand Sanitizer, API’s (active pharmaceutical ingredients) and homeopathic, herbal and dietary supplements. Who is responsible to for Drug registration and Drug listing?  The manufacturer is primarily responsible; however, the Drug importer and/or distributor also has the responsibility for Drug registration. The five process steps for Drug registration and Drug listing : Does your firm have a Duns & Bradstreet (DnB) number (or DUNS number)? If no- go to www.dnb.com where you can initiate the registration  for free if located in the US and not time restricted.  Obtaining a DUNS number for a foreign firm may take time.Next step, register with FDA for a...

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FDA Issues Emergency Use Authorization (EUA) for Face Masks/Respirators to Expedite Importation into U.S

FDA Issues Emergency Use Authorization (EUA) for Face Masks/Respirators to Expedite Importation into U.S

Due to the novel coronavirus/SARS-CoV-2/COVID-19 rapid infection rate, as well the viruses ability to create asymptomatic carriers, resulting in major societal disruptions and shutdowns have occurred throughout the world, but nowhere has this pandemic hit hardest than within the health care systems, hospitals and clinics. Due to the enormous surge of critical care, there is a massive demand and shortage of Personal Protective Equipment (PPE) including surgical and medical gowns, masks, respirators and other critical ventilator equipment. Due to the high number of infections, the need is especially acute in the United States. This is a result of both limited and aged government stockpiles, limited supplies at the manufacturing facilities due to “Just in time” manufacturing, as well as the shutdown of Asian manufacturers during the pandemic. Conversely, during the beginning of the infection in Wuhan, the Chinese government purchased over two billion surgical masks from countries around the world1.   But as soon as China and parts of Asia had managed to slow the spread and lower their curve...

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How to fight the coronavirus SARS-CoV-2 and its disease, COVID-19 – Michael Lin, PhD-MD

How to fight the coronavirus SARS-CoV-2 and its disease, COVID-19 – Michael Lin, PhD-MD

A very informative and detailed overview of the SARS-CoV-2 or novel Coronavirus from a Stanford Doctor, Michael Lin, as well as a bonus recipe at end for making hand sanitizer. Links referenced in Slides Slide 3: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htmSlide 4: https://abcnews.go.com/Health/covid19-days-surfaces-experiment-findings/story%3Fid=69569397Slide 5: https://www.vox.com/2020/2/14/21135208/coronavirus-wuhan-china-covid-19-name-sars-cov-2Slide 6: https://www.ncbi.nlm.nih.gov/pubmed/31971553, https://www.ncbi.nlm.nih.gov/pubmed/15280490Slide 7: http://doi.org/10.1101/2020.03.09.20033217, https://www.ncbi.nlm.nih.gov/pubmed/22312351Slide 8: https://en.wikipedia.org/wiki/2020_coronavirus_pandemic_in_South_Korea, https://wwwnc.cdc.gov/eid/article/26/6/20-0320_article, https://www.worldometers.info/coronavirus/country/south-korea/Slide 9: https://cmmid.github.io/topics/covid19/severity/diamond_cruise_cfr_estimates.html, http://www.wsj.com/articles/experimental-drug-helps-some-americans-ride-out-coronavirus-nih-doctor-says-11584094955, https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdfSlide 10: https://www.kcra.com/article/coronavirus-covid19-california-sacramento-latest-information/31406140, https://www.medrxiv.org/content/10.1101/2020.03.09.20033357v1, https://wwwnc.cdc.gov/eid/article/26/5/20-0146_articleSlide 11: https://cmmid.github.io/topics/covid19/severity/diamond_cruise_cfr_estimates.html, http://www.medrxiv.org/content/10.1101/2020.03.03.20030593v1, http://www.medrxiv.org/content/10.1101/2020.03.09.20033357v1, http://www.who.int/news-room/q-a-detail/q-a-coronavirusesSlide 12: http://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.htmlSlide 13: http://www.vox.com/2020/3/12/21176783/coronavirus-covid-19-deaths-china-treatment-cytokine-storm-syndrome, http://www.medrxiv.org/content/10.1101/2020.03.03.20030593v1, https://www.statnews.com/2020/03/10/simple-math-alarming-answers-covid-19/Slide 15: http://www.medrxiv.org/content/10.1101/2020.03.03.20030593v1, https://www.ncbi.nlm.nih.gov/pubmed/22312351Slide 17: https://doi.org/10.1016/j.cell.2020.02.052, https://www.ncbi.nlm.nih.gov/pubmed/25666761Slide 18: https://ncbi.nlm.nih.gov/pubmed/32020029, https://www.ncbi.nlm.nih.gov/pubmed/26798032, https://asia.nikkei.com/Spotlight/Coronavirus/China-says-Japan-developed-drug-Avigan-works-against-coronavirus, https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052Slide 19: https://ncbi.nlm.nih.gov/pubmed/32020029, https://www.ncbi.nlm.nih.gov/pubmed/19506054, https://www.ncbi.nlm.nih.gov/pubmed/32074550, https://www.drugs.com/mtm/chloroquine.html, http://www.startribune.com/university-of-minnesota-to-test-three-drugs-for-covid-patients/568766632/Slide 20: https://www.ncbi.nlm.nih.gov/pubmed/32020029, http://www.wsj.com/articles/experimental-drug-helps-some-americans-ride-out-coronavirus-nih-doctor-says-11584094955Slide 21: http://www.vox.com/2020/3/12/21176783/coronavirus-covid-19-deaths-china-treatment-cytokine-storm-syndrome, https://www.pharmaceutical-technology.com/news/roche-actemra-coronavirus-complications, http://www.startribune.com/university-of-minnesota-to-test-three-drugs-for-covid-patients/568766632/, http://www.nature.com/articles/nrd1830, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30116-8/fulltextSlide 22: https://www.nature.com/articles/s41467-019-10280-3, https://www.drugdiscoveryonline.com/doc/stonewise-ai-driven-drug-discovery-polymerase-inhibitors-covid-infection-treatment-0001, https://www.chemistryworld.com/news/rna-vaccines-are-coronavirus-frontrunners/4011326.article, https://doi.org/10.1021/acscentsci.0c00272, https://www.ncbi.nlm.nih.gov/pubmed/15837221, https://www.nature.com/articles/s41541-020-0170-0Slide 23: http://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-testing-intl-hnk/index.html, http://www.propublica.org/article/the-fda-is-forcing-the-cdc-to-waste-time-double-testing-some-coronavirus-cases, https://www.aamc.org/news-insights/coronavirus-testing-how-academic-medical-labs-are-stepping-fill-void, https://www.fiercebiotech.com/medtech/fda-grants-roche-coronavirus-test-emergency-green-light-within-24-hoursSlide 25: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/children-faq.html, https://www.cdc.gov/coronavirus/2019-ncov/summary.htmlSlide 31: http://www.nytimes.com/2018/03/23/well/live/face-masks-work-healthy-colds-flu-immunity-prevention.html, https://www.ncbi.nlm.nih.gov/pubmed/23505369, https://www.ncbi.nlm.nih.gov/pubmed/19193267,...

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Glen Feye, MS, and CQE

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Dilip Ashtekar, Ph.D.

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Sebastian Feye, BSC

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