A robot hand signing a piece of paper. In the background is a gavel and overlaid on top of the image are scales which are commonly used to depict justice.

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 ...

a pill floating between the hands of a doctor with various safety reports and graphs surrounding the pill

Revolutionizing Pharmacovigilance with Proactive Signal Detection

Up to now, drug safety teams have relied primarily on reactive reporting systems for ...

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 ...

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 ...