What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective
- Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements;
- Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies;
- Regulatory NC considerations and approach;
- Take-home messages: integrated approach CMC / nonclinical / clinical.