Regulatory Actions in May 2026

Welcome to PharmTech’s Regulatory Roundup for May 2026.

In the United States, the FDA experienced leadership change, made advances in treatments for unmet needs, and issued a variety of guidance documents in May 2026.

On May 6, the agency announced the launch of one-day inspectional assessments.1 The pilot program focuses on shorter screening assessments that will complement standard inspections. The agency stated these assessments will support a more robust risk model across agency programs.

“Global health authorities are increasingly utilizing structured data to drive inspections, scientific decision-making, or to identify a shortages critical medicines,” says Joseph Albanese, managing director and consultant with Albanese Consulting, LLC. “Pharmaceutical stakeholders should be aware of this evolution, as it will fundamentally change how they interact with these authorities moving forward.”

“The one-day inspection assessment approach appears to be beneficial and help with the resource allocation and allows the FDA to do more inspections,” says Rory Budihandojo, an independent GMP consultant. “For the industry, it also means less resources needed in hosting the inspection (as opposed to a multiday inspection). However, perhaps other inspectional related steps can also be looked at and be made more efficient. For example, the EIR (Establishment Inspection Report) that the inspector has to prepare after an inspection, it typically takes a significant amount of time to write and prepare. Perhaps this EIR step can be made faster by using voice recording (which can be transcribed) or maybe even a video report instead of a manual textual report.” 

Watch everything you need to know in under 4 and a half minutes and/or read on about how the FDA is advancing treatments for unmet needs, recent FDA guidance documents, FDA workshops in June, and what's new with European Regulations!