FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 [...]

If you want to know where regulatory expectations are headed, you don’t always need a new guidance document. Sometimes you just need to listen to what regulatory pros keep arguing about. Across recent discussions, three [...]

In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]

The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political shifts, leadership changes, and funding concerns, the regulatory landscape is [...]

Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and [...]

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination [...]