Resources

In today’s rapidly evolving healthcare landscape, connected medical devices—those that transmit, receive, or act on data—represent some of the most innovative yet complex tools entering the market. These products, often...

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI Group to unpack the evolving...

Background An established pharmaceutical company with a strong background in biologics and biosimilars was preparing to enter Phase 3 clinical trials with a biosimilar product. While their drug development and...

A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch for an in-depth exploration of PDA/ANSI Standard 06-2025: Assessment of Quality Culture, a...

Combination product submissions require a tailored regulatory strategy that blends device, drug, and biologic requirements. The complexity increases when multiple FDA centers could be involved. The journey begins with identifying...

Why Design Controls Matter for Combination Products Design controls represent one of the most significant regulatory challenges for companies entering the combination product market, especially those with a pharmaceutical or...