FDA Law Blog
OCTOBER 3, 2022
Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.
FDA Law Blog
OCTOBER 24, 2023
Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.
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FDA Law Blog
JUNE 23, 2021
For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). 25, 2014).
FDA Law Blog
MAY 7, 2025
In the absence of such evidence, the Court held that Sorensens volume-based (i.e., percentage-based or per-lead) compensation structures did not violate the AKS. Shoemaker, 746 F.3d 3d 614, 627-28 (5thCir. In Practice Volume-based compensation arrangements for independent contractor sales agents and marketers have long been a concern for HHS OIG.
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. 1316.05.
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. 1316.05.
PEMBlog
MARCH 27, 2024
My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. So my special guest host on this episode is a trainee in pediatrics and medical genetics. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: [link] Rice GM, Steiner RD.
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