Regulatory Beat: Biotech Innovation Benefits From Streamlined Manufacturing Policy
March 1st 2006As part of its campaign to facilitate research on drugs and medical products, the Food and Drug Administration (FDA) recently issued new policies to encourage sponsors to conduct more informative and less costly early clinical trials. A new guidance on exploratory investigational drug applications (INDs) explains how scientists in industry and academia may test very small doses of a candidate compound to detect any pharmacologic effect before investing in more extensive in vitro and animal studies required for conventional phase 1 trials. The goal is to quickly identify products that show some promise of efficacy, and to halt research on those that fail to hit preliminary targets.
Operations Excellence: BioPharmaceutical Operations Excellence -- 2006 and Beyond
March 1st 2006. . . Popular consortium meetings have focused on successful use of tools to drive improvement in cycle time reduction, deviation reduction, and improved production efficiency.