The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now enjoys a measure of stability that reduces the risk of future funding lapses. But that [...]

The FDA’s updated guidance on Unique Device Identification (UDI) for combination products, updated as of June 2025, has stirred conversation across the industry. For companies developing products that merge drug, biologic, and device components, labeling has always been a regulatory gray zone. Now, the FDA’s latest updates, intended to clarify [...]

The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and access to key resources frozen, the FDA has announced that it will not accept or [...]

Starting today, October 6th, and ending on October 7th, regulatory professionals from around the world will gather in Pittsburgh, Pennsylvania for RAPS Convergence 2025, the go-to conference for insights, networking, and future-focused discussions in medical devices, pharma, diagnostics, and more. Pre-conference workshops will take place on October 6 and 7, [...]