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

  Рет қаралды 2,492

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

In this FDA Drug Topics Continuing Education webinar, Cameron Wilson and Lieutenant Commander Mitchell Chan, will be discussing the FDA Oncology Center of Excellence's Project Facilitate an overview of oncology expanded access programs.
Chapters:
00:00 - Introduction
00:09 - Welcome Remarks
03:25 - Cameron Wilson
17:50 - Lieutenant Commander Mitchell Chan
45:27 - Questions and Answers
Resources:
FDA Project Facilitate Website: www.fda.gov/about-fda/oncolog...
FDA Expanded Access Site: www.fda.gov/news-events/publi...
Reagan-Udall Foundation EA Navigator: navigator.reaganudall.org/exp...
eRequest: erequest.navigator.reaganudal...
Form 3926: www.fda.gov/media/98616/download
Instructions for 3926: www.fda.gov/media/98627/download
FDA Drug Info Rounds Expanded Access Video Series: www.fda.gov/drugs/information...

Пікірлер
Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy
48:50
Navigating First ICH Generic Drug Draft Guideline M13A Bioequivalence for IR Solid Oral Dosage Forms
2:25:28
Mom's Unique Approach to Teaching Kids Hygiene #shorts
00:16
Fabiosa Stories
Рет қаралды 35 МЛН
Best KFC Homemade For My Son #cooking #shorts
00:58
BANKII
Рет қаралды 69 МЛН
Conversations on Cancer: Bringing Innovation to People Facing Cancer
1:01:47
U.S. Food and Drug Administration
Рет қаралды 2,9 М.
Module 5 - Why Use Models to Inform Decisions?
1:00:59
U.S. Food and Drug Administration
Рет қаралды 123
Environmental Monitoring in Compounding
1:22:55
U.S. Food and Drug Administration
Рет қаралды 125
Importing FDA-Regulated Products: Human Foods
13:30
U.S. Food and Drug Administration
Рет қаралды 23 М.
Module 6 - Applying MIDD Strategies to Decision-Making
1:29:45
U.S. Food and Drug Administration
Рет қаралды 143
Module 4 - Case Study 4: Vaccine PKPD, MBMA, and Beyond
30:47
U.S. Food and Drug Administration
Рет қаралды 153
Module 8 - Part 1: Introduction to Digital Health
13:58
U.S. Food and Drug Administration
Рет қаралды 136
Module 8 - Part 5: Real-World Data (RWD) & Real-World Evidence (RWE)
16:08
U.S. Food and Drug Administration
Рет қаралды 130
Module 7 - Case Study 5:  Application of PBPK Models in Eliglustat Clinical Development
15:43
Todos os modelos de smartphone
0:20
Spider Slack
Рет қаралды 64 МЛН
Tag him😳💕 #miniphone #iphone #samsung #smartphone #fy
0:11
Pockify™
Рет қаралды 3,1 МЛН
low battery 🪫
0:10
dednahype
Рет қаралды 1,6 МЛН
Looks very comfortable. #leddisplay #ledscreen #ledwall #eagerled
0:19
LED Screen Factory-EagerLED
Рет қаралды 9 МЛН