On May 29, 2026, FDA issued its final guidance, “Content of Human Factors Information in Medical Device Marketing Submissions.” The guidance provides a risk-based framework for determining what human factors information should be documented and [...]

On April 16, 2026, FDA’s Center for Devices and Radiological Health (CDRH) issued a Letter to Industry warning manufacturers of CDRH-led combination products about the potential for nitrosamine impurities and outlining what manufacturers should be [...]

Combination products don’t usually fail because the science is weak, they fail because teams hit avoidable friction: the wrong lead center, unclear expectations across centers, duplicated information, and quality system gaps that surface late. Two [...]

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 [...]

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 [...]

The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled "Alternative Tools for Assessing Manufacturing Facilities Named [...]