Some of the ICH guideline documents have undergone several revisions to get to the guidelines in use today. It also is reassuring to know that, periodically, guideline documents are identified as needing to be updated due to many factors, including evolving science.
The microbiome has become the object of interest for many companies and researchers hoping to develop therapeutics that manipulate it. Of course, with any new frontier, there are plenty of challenges, both for regulators and for formulators, that must be navigated to ensure consumer safety.
On Sunday afternoon, I attended the Continuing Education course titled “Detecting Cancer Risk in Drugs: Design, Conduct, and Interpretation of Carcinogenicity Studies for Regulatory Approvals.” Dr. McMaster opened the course with an overview of current procedures of carcinogenicity testing of drugs.