Mobile Medical Apps & FDA Rules: What is the latest in 2017?

By |December 3rd, 2017|Regulatory Compliance|

In the world of mobile apps, things change quickly, and it stands to reason that, as mobile phone makers added [...]

EU Medical Device Industry: Regulatory and Privacy M&A Issues for a US Company

By |December 3rd, 2017|Regulatory Compliance|

For US healthcare companies considering an acquisition of a medical device or in vitro diagnostics company in the EU or [...]

FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?

By |September 13th, 2017|Regulatory Compliance|

On August 31, 2017, the FDA issued a final version of a guidance entitled, “Use of Real-World Evidence to Support [...]

CMS Releases 2015 Open Payments Data – Value to the Public Still Not Clear

By |July 7th, 2016|Regulatory Compliance|

CMS recently released Open Payments data submitted by applicable pharmaceutical and medical device manufacturers for calendar year 2015, and it [...]

Massive Anti-Kickback, False Claims, and FCPA Settlements for Life Sciences Companies

By |April 18th, 2016|Regulatory Compliance|

In March 2016, two global life sciences companies agreed to pay hundreds millions of dollars in fines to resolve claims [...]

Open Payments 2015 Calendar Year Reporting Period Now Closed; Prepare for Reporting 2016 Data

By |April 8th, 2016|Regulatory Compliance|

The Open Payments reporting period for payments made in calendar year 2015 by applicable pharmaceutical, device, biological, and medical supply [...]