2014 Individual IT Manufacturing 
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
FDA Law Blog
OCTOBER 14, 2024
2014); U.S. The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. Stem Cell Clinic, LLC , 998 F.3d 3d 1302 (11th Cir.
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FDA Law Blog
MAY 7, 2025
Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare. Medicare or Medicaid). Polin , 194 F.3d 3d 863 (7th Cir.
FDA Law Blog
MAY 20, 2021
Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.
FDA Law Blog
MAY 20, 2021
Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.
GeriPal
MARCH 2, 2023
2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications.
GeriPal
DECEMBER 7, 2023
was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US.
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