FDA FDA Revises COVID-19 ANDA Guidance Thomas Sullivan Nov 12, 2021 0 In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug…
Guidelines AdvaMed Releases Code of Ethics on Interactions with Health Care… Thomas Sullivan Nov 11, 2021 0 On October 1, 2021, the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with health care…
Medical Legal Federal Judge Rules in Favor of Eli Lilly, Vacates HHS and HRSA 340B… Thomas Sullivan Nov 10, 2021 0 On October 29, 2021, United States District Court Judge Sarah Evans Barker granted Eli Lilly’s request to vacate two…
Anti Kickback Pharmaceutical Sales Rep Sentenced for Defrauding Insurance Companies Thomas Sullivan Nov 9, 2021 0 Mark Moffett, a former pharmaceutical sales representative for Aegerion Pharmaceuticals Inc., was recently sentenced to 54 months…
Congress Senate Holds Hearing to Discuss the Future of Telehealth Thomas Sullivan Nov 8, 2021 0 On October 7, the Senate Commerce Subcommittee on Communications, Media, and Broadband held a hearing to discuss the future of…
CME CME-CE Programs to Assist Oncologists Diagnose, Treat Advanced Nonmelanoma… Thomas Sullivan Nov 7, 2021 0 Nonmelanoma skin cancers (NMSC), which account for at least 30% of all cancer diagnoses, are an increasing health burden.…
CME CME/CNE/CPE Medical Education Program Helps Physicians Integrate the FDA… Thomas Sullivan Nov 6, 2021 0 Leading continuing medical education provider, Rockpointe, in conjunction with Boston University and Potomac Center for Medical…
GAO GAO Report Indicates Providers Question MIPS Outcomes Thomas Sullivan Nov 5, 2021 0 Some providers question whether the Merit-based Incentive Payment System (MIPS) program is improving the quality of patient care…
CMS CMS Issues Interim Final Rule on Surprise Billing Thomas Sullivan Nov 4, 2021 0 On September 30, the Centers for Medicare & Medicaid Services (CMS) issued its second interim final rule (IFR) to address…
DOJ Astellas Reaches $18 Million Settlement for Underpaying Manufacturer… Thomas Sullivan Nov 3, 2021 0 On October 15, 2021, Astellas Pharma U.S., Inc., reached an $18 million settlement for alleged False Claims Act violations. The…