Manufacturing Intelligence: What FDA's NAM Rule Means for CMC Teams

The FDA's September 22 direct final rule, which swaps "animal tests" for "nonclinical tests," gives new approach methodologies (NAMs) firmer regulatory footing, but its real impact on development and CMC timelines is still taking shape. On episode 7 of PharmTech's Manufacturing Intelligence, co-host sChris Cole and Richard Jaenisch, MPH, a liver transplant recipient and patient advocate, speak about what the rule and FDA's accompanying database of roughly 25 real-world NAM use cases mean for sponsors, regulators, and manufacturing teams.