Avoiding the Patient Assistance Program Spotlight
In efforts to understand the rising cost of some drugs, Patient Assistance programs, particularly independent…
Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and…
Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to…
CMS Missing Critical QPP Infrastructure
The United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published a report,…
2017 Biosimilar Update
We have taken an interest in the growing biosimilars market in the United States. Recently, we covered the Friends of Cancer…
FDA Announces Safety Labeling Changes Program
As reported by Regulatory Focus, the FDA announced the “safety labeling changes” (SLC) program. It will be reportedly…
Discussion on Open Payments by Philadelphia-Region Doctors
An article in the Philadelphia Business Journal published in early January 2017 focused on Open Payments and payment…
Department of Justice Increases FCA Civil Penalties, Again
On February 3, 2017, the Department of Justice (DOJ) announced that False Claims Act (FCA) penalties will once again be…
Tom Price on MACRA and Value-Based Care
During the last weeks of the Obama Administration, CMS continued to roll out new mandatory bundled payments models. Rep. Tom Price…
Walgreens to Pay $50M to Settle Anti-Kickback Suit
Walgreen Co. (“Walgreens”) has agreed to pay $50 million to settle allegations that it gave kickbacks to government health care…
Zimmer Biomet Pays $30 Million to Resolve New FCPA Charges
Medical device maker Zimmer Biomet Holdings, Inc., agreed to pay $30.5 million to resolve Department of Justice (DOJ) and…