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. [...]

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 [...]

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 [...]

On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs).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. [...]

FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” It’s aiming at drug manufacturing sites regulated by CDER/CBER/CVM and lays out what FDA expects [...]