'Available therapy' presentation slideshows

Defining Success in Oncology Drug Development

Defining Success in Oncology Drug Development. Richard Pazdur, MD CDER, FDA The views expressed are the results of independent work and do not necessarily represent the views or findings of the United States Food and Drug Administration or the United States. Basis for NDA Approval.

492 views • 26 slides

Regulatory Background and Past FDA Approvals in Colorectal Cancer

Regulatory Background and Past FDA Approvals in Colorectal Cancer. Amna Ibrahim M.D DODP, FDA. Presentation Outline. Regulatory background Past endpoints in Oncology Approvals for colon cancer (adjuvant, first-line and second-line therapy) Studies supporting drug approval

463 views • 26 slides

U.S. Food and Drug Administration

302 views • 20 slides