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 June 29, 2026, FDA announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to advance U.S. drug manufacturing and improve regulatory predictability for new domestic [...]

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 [...]

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 [...]