FDA Publishes Final Guidance on Competitive Generic Therapies
The US Food and Drug Administration (“FDA”) recently issued a final guidance on the Competitive Generic Therapies (“CGT”) program.…
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May 2020
CMS Finalizes Guidance on Pharmaceutical Coupons and Cost Sharing
On Thursday, May 7, 2020, the United States Centers for Medicare and Medicaid Services (CMS) released the 2021 Notice of Benefit…
CMS Launches Program to Lower Insulin Costs
The Centers for Medicare and Medicaid Services (“CMS”) recently announced the new Part D Senior Savings Model, which is intended…
Florida Cancer Specialists Admits to Antitrust Conspiracy
On April 30, 2020, a one-count felony charge was filed against Florida Cancer Specialists & Research Institute (FCS), alleging…
The Impact of COVID-19 on the Hospitality Industry
As the United States slowly starts reopening due to the COVID-19 pandemic, many are wondering how stores, restaurants, and…
Teva Settles AKS Allegations
Earlier this year, Teva agreed to pay $54 million to settle an Anti-Kickback Statute (AKS) and False Claims Act (FCA) claim that…
USAO Sues Spinal Device Company and Executives Over Kickbacks
Earlier this year, it was announced by the United States Attorney’s Office for the District of Massachusetts that a civil health…
FDA COVID-19 Special Emergency Program for Accelerating Research and…
Recently, the Food and Drug Administration (FDA) detailed a new “special emergency program” for accelerating research and…
Managing Pharma and Medical Device Ethics and Compliance Function Remotely
On April 13, 2020, Global Health Care LLC presented a webinar entitled, Managing Pharma and Medical Device Ethics and Compliance…
International Academy for CPD Accreditation Proposed Guidelines for Global…
In February 2020, the International Academy for CPD Accreditation (the Academy) opened a call-for-comment about a proposed set of…