FDA’s Total Product Life Cycle Advisory Program (TAP) continues to expand, giving more medical device innovators the opportunity for earlier, more frequent engagement with FDA during development. As of FDA’s July 2026 TAP update, the [...]

On July 10, 2026, FDA issued a proposed rule that would modernize drug manufacturing registration requirements. If finalized, the rule would create a streamlined registration pathway for distributed manufacturing establishments operating under a hub-and-spoke model. [...]

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 [...]

FDA leadership has seen significant turnover in May 2026, including the resignation of FDA Commissioner Marty Makary, the appointment of Kyle Diamantas as Acting Commissioner, and a change at the top of CDER with Michael [...]

FDA just gave the industry a very clear signal about AI in a cGMP environment. In an April 2, 2026 Warning Letter to Purolea Cosmetics Lab, FDA included a section on “Inappropriate Use of Artificial [...]

On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs). These methods are intended to support drug development decisions without relying on traditional animal testing as the default. [...]