The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...

This guidance provides the agency’s current thinking on establishing a routine sanitation program for low-moisture, ...

The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable ...

The FDA has ... the heart of the guidance is the concept of 'context of use' (COU), which defines how an AI will be used to address a "question of interest," according to the document.