An Overview of FDA's Project Facilitate Oncology Expanded Access Program Published 2024-01-11 Download video MP4 360p Download video MP4 720p Recommendations 1:56:22 FDA Clinical Investigator Training Course (CITC) 2023, Day 1 – Part 1 1:01:47 Conversations on Cancer: Bringing Innovation to People Facing Cancer 48:50 Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy 1:46:12 Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 2 2:55:17 Increasing the Efficiency of Biosimilar Development Programs (Day 1) 1:02:25 FDA New Era of Smarter Food Safety Tech-Enabled Traceability Video Series: Supply Chain Technology 2:03:33 A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs 2:13:43 FDA Clinical Investigator Training Course (CITC) 2023, Day 2 – Part 2 1:49:10 Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 1 13:30 Importing FDA-Regulated Products: Human Foods 59:43 Bringing Clinical Research to Patients 1:00:31 Hyperemesis Gravidarum: New Research and Insights 04:55 10 Facts about What FDA Does and Does Not Approve #FDAFacts 02:02 5 Things You Need to Know About the Drug Approval Process 03:17 How does the FDA approve new drugs? 08:11 Introduction to ICH E19: Selective Collection of Safety Data in Clinical Trials 02:21 What does the FDA do after drugs are approved? 02:28 What is FDA’s role in regulating drugs? 05:55 10 datos sobre lo que la FDA aprueba y no aprueba #DatosDeLaFDA 7:58:37 Advancing Generic Drugs Development: Translating Science to Approval 2023 - Day 2 Similar videos 1:03:09 Expanded Access Webinar 2:20:58 Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 2-Session 1 6:04:50 Oncologic Drugs Advisory Committee Meeting 29:06 MesoTV | Conversation with the FDA regarding Expanded Access, Compassionate Use for mesothelioma 13:56 Expanded Access discussion at the 2021 FDA Foundation Annual Meeting 01:01 FDA to improve access to experimental cancer drugs 5:20:45 November 16, 2023 Meeting of the Oncologic Drugs Advisory Committee (ODAC) 59:00 What is FDA Project Optimus and How Will it Impact Oncology Drug Development? 1:01:04 Right to Try Act - Expanding Access to Experimental Brain Tumor Treatments 9:26:46 74th Cellular, Tissue, and Gene Therapies Advisory Committee 1:31:45 Conversations on Cancer: Living with Metastatic Breast Cancer 49:45 Framework for FDA’s Real-World Evidence Program – Mar 15, 2019 45:04 Expanded Access Webinar - A Pathway for Early Access to Amyloidosis Treatment 5:20:51 June 16, 2023 Meeting of the pedsODAC 55:02 Planning for Co-development of Companion Diagnostics 55:36 LMSDR Webinar: FDA Oncology Product Development 5:36:30 April 28, 2023 Meeting of the Oncologic Drugs Advisory Committee (ODAC) 1:26:23 Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA More results