Regulatory

How Could the FDA Change Under Scott Gottlieb?

Earlier this month, President Trump nominated Dr. Scott Gottlieb to serve as the new ...

The Impact of Mindset on Regulatory Compliance Efficiency

Trust is key for innovation, competitive advantage, and efficiency when working across countries, departments, ...

Promotional Review Teams—Getting it Right

The 4th Promotional Review Committee Compliance & Best Practices, sponsored by ExL, was chock ...

Laboratory-Developed Tests and the New Administration

On the heels of the recent U.S. Food and Drug Administration (FDA) announcement to ...

Leveraging Patient Preferences and Patient Communications in Device Promotion

As the U.S. Food and Drug Administration (FDA) increasingly focuses on patient engagement in ...

The Mechanics and the Mindset for Mobile App Success

A graveyard full of well-intentioned apps litter tablets and smartphones. The reason: Apps often ...

Surprise, Awareness, Adjustment—And Patients First

I remember the day in 1986 like it was yesterday: The public relations community ...

Medical Device Promotion: The Same Rules of the Road as Rx Drugs?

Many pharmaceutical companies today are crossing over into the medical device world in one ...

Regulatory and Innovation: It’s Possible

Can ad/promo regulatory professionals be innovative thinkers? Some have argued that these two terms ...

How to Apply Objection-Handling to Drug Price Complaint

Every sales and marketing professional is familiar with the term objection-handling, which is used ...

Bringing a Medical Device to Market

Pipeline products are the lifeblood not only of established device companies but also of ...

Imagining an Unimagined World

A quote by futurist Jamais Cascio struck me as highly relevant to our industry. ...