GxP Archives - Quality Solutions Now (QSN)

FDA’s Draft Guidance on Alternatives to Animal Testing: What Quality Teams Should Do Now
On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs).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 “One Pivotal Trial” Default: What It Means for Evidence Quality, Not Just Speed
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 [...]