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 Davis stepping in as acting director after Tracy Beth Hoeg’s departure. This is not a [...]
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 Intelligence in Pharmaceutical Manufacturing.” The core issue wasn’t that the firm used AI, it was [...]
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 doing now to identify and manage the risk. Why FDA is raising this now FDA [...]
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 recent FDA Office of Combination Products (OCP) updates give sponsors a clear opportunity to streamline: [...]
On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs).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’s stated goal is to help sponsors use human-relevant, scientifically rigorous approaches that can support [...]
FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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 when a company chooses to submit a written response to an FDA 483. Core Message: [...]
