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On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs).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FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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 [...]