MLR Comments: Friend or Foe?

When I tell people that I work in pharma marketing, I occasionally get a ...

GDPR: Where We’ve Come, Where We are Going

Recently, I wrote about Google’s $57 million fine for violating the now one-year old ...

Marketing Laboratory Developed Tests

On April 4, 2019, the U.S. Food and Drug Administration issued a Warning Letter ...

How Safe are Safe Harbor Regulations?

The phrase “no more rebates” and recent guidance from the Department of Health and ...

Sprint Through Real-Time Promo Review

Agility benefits the entire value chain process, from basic research to clinical development, to ...

Words & Functionalities Matter: FDA Regulation of Consumer Software and Apps

Today, understanding whether digital health software or apps are actively regulated as medical devices ...

Progress Toward an Ethical Mindset

Everyone agrees that industry must move from rules- to values-based decision-making to ensure compliance ...

Talking About Your Pipeline

Ahead of commercialization, companies developing drugs and medical devices communicate about their pipeline products ...

Optimize Content Quality Globally

With anticipated launches of novel therapies and increasing sales for currently marketed prescription products, ...