Policy and Medicine Compliance Update April 2023 Issue Features: DOJ’s…
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April 2023
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FDA Issues Draft Guidance on Dosage and Administration Labeling Section
The United States Food and Drug Administration (FDA) released draft guidance focused on improving the consistency of information…
Transparency in Coverage Data Could Use Improvements
A recent report from the Georgetown University Center for Children and Families argues that certain changes and reforms are needed…
DEA Publishes Requirements for MATE Act One Time Requirement for Eight…
The United States Drug Enforcement Administration (DEA) recently published the requirements for training for the Medication Access…
American Board of Surgery Announces Changes to MOC Credit Reporting
The American Board of Surgery recently announced changes to the way diplomates receive Maintenance of Certification (MOC, or…