FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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 [...]