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 ...

Expedite the MLR Review Process—Engage Audiences with Your Content Faster

How are you approaching audience engagement at your organization? Perhaps you’re putting an emphasis ...