FDA CBER Director Dr. Peter Marks Discusses Industry Growth, Collaboration and Communication
FDA CBER Director Dr. Peter Marks Discusses Industry Growth, Colla…
Jul 8, 2024
biospace.com
CFRR INFOMERCIAL - Food and Drug Administration
CFRR INFOMERCIAL - Food and Drug Administration
Jul 9, 2020
fda.gov.ph
Electronic Submission of Adverse Event Reports to FDA FAERS
Electronic Submission of Adverse Event Reports to FDA FAERS
Apr 28, 2019
fda.gov
Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO
Communication Best Practices – Interacting with Regulatory Projec…
1.8K viewsJul 30, 2021
YouTubeU.S. Food and Drug Administration
Jobs at FDA
Jobs at FDA
Apr 26, 2019
fda.gov
FDA CCP = e-Submission of FDA eSTAR eCopy SBD requests
FDA CCP = e-Submission of FDA eSTAR eCopy SBD requests
Jul 24, 2022
medicaldeviceacademy.com
Digital IND Safety Reporting - Pharmacovigilance 2020
27:21
Digital IND Safety Reporting - Pharmacovigilance 2020
3.1K viewsJun 16, 2020
YouTubeU.S. Food and Drug Administration
48:21
FDA Adverse Event Reporting System (FAERS) Overview - Phar…
9.6K viewsJun 15, 2020
YouTubeU.S. Food and Drug Administration
29:42
CMC Considerations for CAR T Cell Product Development
14.6K viewsApr 15, 2021
YouTubeU.S. Food and Drug Administration
30:29
CMC Considerations for Oncolytic Viral Product Development
3.2K viewsApr 15, 2021
YouTubeU.S. Food and Drug Administration
26:21
Regulatory Policy: Role in Guiding Decision Making in CDER
862 viewsJul 30, 2021
YouTubeU.S. Food and Drug Administration
3:41
FDA CDER Regulatory Science: Patient-Focused Drug Development
5K viewsNov 16, 2017
YouTubeU.S. Food and Drug Administration
3:56
FDA CDER Regulatory Science: Real World Evidence
5.8K viewsNov 16, 2017
YouTubeU.S. Food and Drug Administration
8:58:15
FDA Regulatory Education for Industry (REdI) – Devices and Biol…
8.5K viewsJul 22, 2021
YouTubeU.S. Food and Drug Administration
38:21
NDA and BLA Application Review Process (6of15) REdI Annual Conf…
16.8K viewsMar 27, 2020
YouTubeU.S. Food and Drug Administration
1:08:12
Process Validation Principles and Protocols for Medical Devices
28K viewsJun 7, 2016
YouTubeGlobalCompliance Panel
46:52
Preclinical Considerations for Cell and Gene Therapy Products, an F…
18.6K viewsApr 15, 2021
YouTubeU.S. Food and Drug Administration
34:37
Lifecycle Changes to Chemistry, Manufacture, and Controls in NDA…
4.3K viewsAug 31, 2020
YouTubeU.S. Food and Drug Administration
28:11
Post-approval Considerations for Changes to Manufacturing Proces…
14.8K viewsAug 31, 2020
YouTubeU.S. Food and Drug Administration
27:10
Overview of Post-approval Chemistry, Manufacture, and Cont…
10K viewsAug 31, 2020
YouTubeU.S. Food and Drug Administration
31:16
FDA Guidance on Conduct of Clinical Trials of Medical Product…
2.2K viewsJul 30, 2021
YouTubeU.S. Food and Drug Administration
36:56
FDA’s Clinical Regulatory Perspective: Designing First-In-Hu…
7.7K viewsApr 15, 2021
YouTubeU.S. Food and Drug Administration
1:00:28
Writing the “Indications and Usage” Section of Labeling: FDA’s New Dr…
1.9K viewsApr 13, 2020
YouTubeU.S. Food and Drug Administration
46:23
Electronic Common Technical Document (eCTD)
13.2K viewsJul 29, 2021
YouTubeU.S. Food and Drug Administration
5:51
CBER - Active Supervision Training Brief
3.6K viewsSep 14, 2012
YouTubeUConn Neag School of Education
3:32
About FDA’s Data Standards Program
6.1K viewsMay 4, 2017
YouTubeU.S. Food and Drug Administration
1:06
What Does FDA Do?
153.9K viewsOct 3, 2022
YouTubeU.S. Food and Drug Administration
12:34
Mid-Review Cycle Meeting Overview
1.2K viewsMay 13, 2021
YouTubeU.S. Food and Drug Administration
1:09:45
Plenary Session
630 viewsJul 28, 2021
YouTubeU.S. Food and Drug Administration
19:58
Center Director’s Decision Memo
8.7K views7 months ago
YouTubeU.S. Food and Drug Administration
See more videos
Static thumbnail place holder