Regulatory

Healthcare Watch

DC DISPATCH Pay-to-Delay Supreme Bound? Last month, the 3rd Circuit Court of Appeals surprised ...

Off-Label or Off Course?

Drug-makers are mostly prohibited from disseminating information on unapproved uses of approved products. Sometimes, ...

Aggregating Research Payments from Multiple CROs

Last month, the Centers for Medicare & Medicaid Services (CMS) published proposed regulations for ...

Aggregate Spend Compliance: Invest Now or Pay Later

It’s January–CMS has finally published proposed regulations further clarifying the Physician Payment Sunshine Act ...

Risk Evaluation and Mitigation Strategy (REMS)

The FDA is taking action to protect patients from harm caused by high risk ...

Regulatory Compliance: The Importance of Training the Field Sales Force

The manner in which life sciences companies interact with healthcare practitioners and healthcare organizations ...

Use Regulatory Compliance to Your Advantage

U.S. state and federal disclosure laws and the trend towards global transparency have created ...