Regulatory
Marketing Laboratory Developed Tests
On April 4, 2019, the U.S. Food and Drug Administration issued a Warning Letter ...
Patients in Favor of New DTC TV Price Transparency Rule
Last month, the U.S. Department of Health and Human Services (HHS) finalized the new ...
MedCrypt Offers Easy to Implement Medical Device Security
The ability for someone to hack into a medical device, like a pacemaker, is ...
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 ...
From Capitol Hill to the Oval Office: What Washington Has in Store for Pharma and Healthcare Communications in 2019
With 71% of voters citing it as their foremost concern, healthcare was among the ...
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, ...
Patient Experience Data and R&D
As the U.S. Food and Drug Administration (FDA) works to issue more guidance for ...
Technology Optimized Content
With the sheer volume and complexity of promotional materials today, it’s not surprising that ...
PFDD: A Game Changer?
The 21st Century Cures Act (Cures Act), which was passed by Congress, includes mandates ...
