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_fda-483-observations-and-warning-letter-citations-2019-2020-fda-drug-gmp-john-lee-video-2-of-9.webp "This 2nd video (out of 9 in total) focuses on FDA Form 483 observations and Warning Letters, overall statistics for 2019 (and partly 2020) for Drug GMP.nnHere you will find, a 9% increase in number of FDA-483's in 2019 compared to 2018. In absolute numbers, 779 FDA-483’s in 2019 as compared to 716 in 2018.nnTop 3 issues in FDA-483’s are in 2019 (still) violation of CFR,n• 211.22(d), Quality Assurance Oversightn• 211.192, Investigationsn• 211.160(b), Laboratory Controlnn98 Warning Lette")
FDA-483 observations and Warning Letter citations 2019 – 2020. FDA Drug GMP (John Lee, Video 2 of 9)
⏲ 4 min 50 sec ✓ 29-Oct-2020
_frequent-us-fda-observations-2019-amp-how-to-respond-to-fda.webp "Pharma Best Practices Webinars")
_fda-483-observations-and-warning-letter-citations-2019-2020-fda-drug-gmp-john-lee-video-2-of-9.webp "Genau u0026 More A/S More")
FDA-483 observations and Warning Letter citations 2019 – 2020. FDA Drug GMP (John Lee, Video 2 of 9)
⏲ 7 minutes 31 seconds 👁 132
_growing-number-of-americans-are-trying-weight-loss-drugs.webp "Growing , Number of Americans Are Trying , Weight-Loss Drugs.<br/>According to a recent poll, six percent of adults <br/>in the United States have already tried Ozempic <br/>or other brand name weight loss medications.<br/>According to a recent poll, six percent of adults <br/>in the United States have already tried Ozempic <br/>or other brand name weight loss medications.<br/>'Newsweek' reports that the Gallup poll numbers<br/>suggest that approximately 15.5 million Americans have <br/>used or are using an injectable diabetes medication. .<br/>'Newsweek' reports that the Gallup poll numbers<br/>suggest that approximately 15.5 million Americans have <br/>used or are using an injectable diabetes medication. .<br/>According to the poll, three percent <br/>of those users are specifically <br/>using the drug for weight loss.<br/>The poll found that people between the ages <br/>of 40 and 64 are the most likely to try Ozempic <br/>or competitors, like Wegovy or Saxenda. .<br/>In 2017, the U.S. Food and Drug <br/>Administration (FDA) approved Ozempic <br/>to treat cardiovascular disease and diabetes. .<br/>'Newsweek' reports that while Ozempic has <br/>not been approved for weight-loss purposes, <br/>its competitor Wegovy was approved in 2021. .<br/>'Newsweek' reports that while Ozempic has <br/>not been approved for weight-loss purposes, <br/>its competitor Wegovy was approved in 2021. .<br/>Both drugs rely upon the active ingredient <br/>semaglutide, however, Wegovy contains <br/>a higher amount than Ozempic.<br/>Both drugs rely upon the active ingredient <br/>semaglutide, however, Wegovy contains <br/>a higher amount than Ozempic.<br/>The popularity of the drug has resulted <br/>in various makers reporting shortages. .<br/>The drug companies didn't <br/>anticipate how popular <br/>these drugs would become, Sue Decotiis, Triple-board-certified medical <br/>weight-loss doctor in New York City, via 'Newsweek'.<br/>Since they are being used <br/>for many issues, like diabetes, <br/>heart failure, obesity, <br/>this exacerbates the <br/>shortages significantly, Sue Decotiis, Triple-board-certified medical <br/>weight-loss doctor in New York City, via 'Newsweek'")
_most-common-issues-with-cdisc-send-data-in-fda-toxicology-review-sep-12-2019.webp "U.S. Food and Drug Administration")
⏲ 54 minutes 21 seconds 👁 2.8K
_2019-ccts-fda-conference-cder-bimo-compliance-and-enforcement.webp "OSU Center for Clinical and Translational Science")
_otd-in-space-may-20-nasa-launches-pioneer-venus-1.webp "On May 20, 1978, NASA launched a spacecraft to Venus. <br/><br/>The mission was called Pioneer-Venus 1, but it’s also known as the Pioneer Venus Orbiter. This was the first of two spacecraft that made up the Pioneer Venus mission. Pioneer Venus 2 launched a couple months later, and that spacecraft dropped five probes onto the surface of Venus. NASA called this the Pioneer Venus Multiprobe. The orbiter was designed to study the atmosphere of Venus. It was a solar-powered cylinder about the size of a hot tub. The mission launched from Cape Canaveral on an Atlas-Centaur rocket and reached Venus about six months later. While orbiting Venus, it measured the structure of the upper atmosphere and studied how the solar wind interacts with its ionosphere and magnetic field. It also detected gamma-ray bursts and made ultraviolet observations of comets. Pioneer Venus 1 continued to beam back data for 14 years before its decaying orbit sent it into Venus’s atmosphere, where it was destroyed.")
_postmarketing-drug-safety-compliance-2019-inspection-findings.webp "U.S. Food and Drug Administration")
_top-483-warning-letter-observations-from-2019-pathwise-minute-march-16.webp "PathWise")
_mon-11mar24-year-4-of-globalist-war-yet-americans-ready-to-re-elect-quislings.webp "(2:00) On this day, FOUR YEARS ago, WHO declared a")
⏲ 109 min 17 sec ✓ 29-Mar-2024
_how-to-respond-to-fda-483-observations-key-considerations-and-best-practices.webp "Pharmaguideline")
⏲ 4 minutes 39 seconds 👁 624
_fda-inspection-and-audit-common-findings.webp "Stanford Center for Clinical Research")
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