GMP and Phase I Clinical Trials: Streamlining the Critical Path?

Special Issues

LCGC Supplements, Special Issues-07-01-2006, Volume 0, Issue 0

FDA is modernizing and streamlining the regulatory processes for product development. This article examines FDA's proposed rule to exempt the production of Phase 1 clinical trial materials from the GMP regulations and questions whether this proposed exemption will truly improve public health and promote faster and more predictable access to new medicines.