Regulatory
What Biden’s AI Executive Order Means for Healthcare and the Life Sciences
In the dynamic landscape of modern business, regulated industries—such as healthcare and the life ...
Revolutionizing Pharmacovigilance with Proactive Signal Detection
Up to now, drug safety teams have relied primarily on reactive reporting systems for ...
Trends and Challenges in Diabetes Management Devices
During the last 100 years since the discovery of insulin, a hormone that helps ...
How to Stay Compliant with State Drug Price Transparency Reporting
Drug price transparency (DPT) laws have been in effect in several states for a ...
Supporting Innovation Through FDA’s Breakthrough Device Program
Similar to the drug industry’s paradigm for Breakthrough Therapy Designation, the device industry’s opportunity ...
How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels
When developing content for new drug labels, life sciences companies’ regulatory teams face challenges ...
Rob Califf and the Future of Accelerated Approval
If the regulatory, policy, and political temper tantrums over the FDA’s approval of Exondys ...
Digital Therapeutics Companies Lean into Decentralized Clinical Trials
While digital therapeutics (DTx) companies are extremely optimistic about the promise of software-based interventions ...
Bringing Clarity to Cannabis-Based Product Conundrums
The 2018 Farm Bill redefined the meaning of hemp, opening the door to small ...
3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices
Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine ...
The Steps to Take for a Rx-to-OTC Switch in the United States
Nearly 40% of all the over-the-counter medications in the U.S. were initially marketed as ...
How to Accelerate the Approval Process for Marketing Materials Within the Life Sciences
Thanks to the exponential growth of the internet and the rapid take-up of technological ...
Common Pitfalls That Can Be Avoided During Clinical Development
During the clinical development of pharmaceuticals, it is not uncommon for a program to ...
