Slide 1 Tools to Reduce Phase III Trial Failures Lawrence J. Lesko, Ph.D., FCP Director of the Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation…
Slide 1 Critical Path: Overview of Selected Ongoing CBER Efforts and Future Opportunities Jesse L. Goodman, M.D., M.P.H Director Center for Biologics Evaluation and Research…
FDA Critical Path Initiative: A Generic Industry Perspective Shahid Ahmed American Pharmaceutical Partners on Behalf of the Generic Pharmaceutical Association Outline Overview…