Lecture 3 - FDA Drug Approval 101- Reading and Interpreting Cancer Trials Series

(47:8)

What you should know about FDA Project Optimus for your oncology drug approval

(42:27)

FDA Oncology Center of Excellence’s Project Facilitate

(1:24)

An Overview of FDA's Project Facilitate Oncology Expanded Access Program

(50:9)

FDA Oncology Center of Excellence’s Project Facilitate

(3:48)

Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop

(15:50)

HER2-Positive Biliary Tract Cancer: New Developments and Future Directions

(29:16)

Applying the breakthrough therapy criteria: Oncology

(1:35:55)

Modeling and Simulation to Select Oncology Dosages - Session 1

(1:28:43)

Conversations on Cancer: Cancer Moonshot: What’s happened since 2017?

(1:8)

Project Optimus – FDA’s New Dose Optimization \u0026 Selection Paradigm in Oncology Drug Development

(1:5:36)

Assessing the Impact of FDA Accelerated Approval in Oncology

(4:34)

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

(54:26)

Getting to First-in-Human for Small Molecules and Biologics

(31:53)

Designing First-In-Human Trials for Small Molecules and Biologics

(37:34)

The FDA’s \

(12:7)

FDA Approval Considerations with Dr. Paul Kluetz

(53:28)

The Impacts of FDA Regulations on Diagnostics in Oncology

(31:22)

Oncology eCOA: What the New FDA Draft Guidelines Tell Us

(59:49)

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

(31:44)