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 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 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On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs).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FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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: [...]
On February 18, 2026, FDA leadership signaled a major shift in how effectiveness is demonstrated for most drugs: the default expectation will be one adequate and well-controlled pivotal study, paired with confirmatory evidence, rather than the long-standing “two confirmatory trials” norm. FDA Commissioner Marty Makary and Vinay Prasad described the [...]
On February 2, 2026, FDA’s revised 21 CFR Part 820 - now titled the Quality Management System Regulation (QMSR) - became effective. The key change is that FDA now incorporates ISO 13485:2016 by reference as the backbone of device CGMP requirements. If your organization has been “ISO-ish” but not fully [...]
FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s a regulatory expectation. In December, the U.S. Food and Drug Administration announced the launch of [...]
