DOJ DOJ Withdraws Three Policy Statements Regarding Health Care Antitrust… Thomas Sullivan Apr 17, 2023 0 The United States Department of Justice (DOJ) recently withdrew three policy statements regarding health care antitrust…
Compliance Policy and Medicine Compliance Update April 2023 Issue Features: DOJ’s… Thomas Sullivan Apr 15, 2023 0 Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…
International Paris Appeals Court Overturns Huge Fine Against Novartis and Roche Thomas Sullivan Apr 14, 2023 0 We wrote in 2020 about the hefty fines levied against Novartis and Roche for allegedly engaging in anti-competitive practices with…
Government Agencies FDA and HHS Need to Improve Tracking and Monitoring of IRBs Thomas Sullivan Apr 13, 2023 0 The Government Accountability Office (GAO) recently released a report, saying the United States Food and Drug Administration (FDA)…
Guidelines SAMHSA Publishes FAQs on Removal of X-Waiver Requirement Thomas Sullivan Apr 12, 2023 0 Recently, the Substance Abuse and Mental Health Services Administration (SAMHSA) published frequently asked questions about the…
International Novo Nordisk Suspended as ABPI Member for Serious Breaches of the Code of… Thomas Sullivan Apr 11, 2023 0 Novo Nordisk was recently suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) for two years, as…
Anti Kickback Pennsylvania Department of Human Services Amends Anti-Kickback Rule Thomas Sullivan Apr 10, 2023 0 The Pennsylvania Department of Human Services recently published a final rule amending the Pennsylvania Human Services Code (the…
FDA FDA Issues Draft Guidance on Dosage and Administration Labeling Section Thomas Sullivan Apr 7, 2023 0 The United States Food and Drug Administration (FDA) released draft guidance focused on improving the consistency of information…
Transparency Transparency in Coverage Data Could Use Improvements Thomas Sullivan Apr 6, 2023 0 A recent report from the Georgetown University Center for Children and Families argues that certain changes and reforms are needed…
CME DEA Publishes Requirements for MATE Act One Time Requirement for Eight… Thomas Sullivan Apr 5, 2023 0 The United States Drug Enforcement Administration (DEA) recently published the requirements for training for the Medication Access…