Comment from Pharmaceutical Research and Manufacturers of America (PhRMA)

Summary: PhRMA, representing leading biopharmaceutical research companies, supports the FDA's Draft Guidance on the Plausible Mechanism Framework for developing individualized therapies. They advocate for a flexible, technology-agnostic approach that broadens the scope of eligible diseases and products while requesting specific clarifications on CMC expectations, observational data, and interactions with existing expedited programs.