CMS Faces Tight Timeline to Implement IRA Rules on Part B and Part D Drug…
The Inflation Reduction Act had far-reaching implications for the health care industry, including the timeline Congress set for…
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The Pill Club Reaches $18 Million California Settlement Over Fraud…
California Attorney General Rob Bonta recently announced a settlement with The Pill Club, an online women’s pharmacy, over…
DOJ Withdraws Three Policy Statements Regarding Health Care Antitrust…
The United States Department of Justice (DOJ) recently withdrew three policy statements regarding health care antitrust…
Policy and Medicine Compliance Update April 2023 Issue Features: DOJ’s…
Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…
Paris Appeals Court Overturns Huge Fine Against Novartis and Roche
We wrote in 2020 about the hefty fines levied against Novartis and Roche for allegedly engaging in anti-competitive practices with…
FDA and HHS Need to Improve Tracking and Monitoring of IRBs
The Government Accountability Office (GAO) recently released a report, saying the United States Food and Drug Administration (FDA)…
SAMHSA Publishes FAQs on Removal of X-Waiver Requirement
Recently, the Substance Abuse and Mental Health Services Administration (SAMHSA) published frequently asked questions about the…
Novo Nordisk Suspended as ABPI Member for Serious Breaches of the Code of…
Novo Nordisk was recently suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) for two years, as…
Pennsylvania Department of Human Services Amends Anti-Kickback Rule
The Pennsylvania Department of Human Services recently published a final rule amending the Pennsylvania Human Services Code (the…
FDA Issues Draft Guidance on Dosage and Administration Labeling Section
The United States Food and Drug Administration (FDA) released draft guidance focused on improving the consistency of information…