🎧 Listen in to learn about a recent FDA advisory committee meeting on the effectiveness of oral phenylephrine as a nasal decongestant with Dr. Theresa Michele from FDA's CDER Office of Nonprescription Drugs & Dr. Ilisa Bernstein from the American Pharmacists Association in our latest episode of Q&A with FDA: https://www.fda.gov/media/177105/download?attachment | U.S. Food and Drug Administration
0:19
FacebookU.S. Food and Drug Administration
🎧 Listen in to learn about a recent FDA advisory committee meeting on the effectiveness of oral phenylephrine as a nasal decongestant with Dr. Theresa Michele from FDA's CDER
U.S. Food and Drug Administration. . 🎧 Listen in to learn about a recent FDA advisory committee meeting on the effectiveness of oral phenylephrine as a nasal decongestant with Dr. Theresa Michele from FDA's CDER Office of Nonprescription Drugs & Dr. Ilisa Bernstein from the American Pharmacists Association in our latest episode of Q&A with ...
342 viewsMar 20, 2024
Related Products
FDA Medical Device
CDER Warning Letters
AIML CDER FDA
#Center for Drug Evaluation and Research Drug Approval Process
FDA Launches ELSA: AI to Revolutionize Drug Approval Process
FDA Launches ELSA: AI to Revolutionize Drug Approval Process
MSN8 months ago
12K views · 22 reactions | Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, discusses the manufacturing process and potential risks associated with CAR T-cell therapy. Gain a deeper understanding of the complexities surrounding this innovative treatment on Intention to Treat: https://nej.md/itt-ep29 | The New England Journal of Medicine | Facebook
12K views · 22 reactions | Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, discusses the manufacturing process and potential risks associated with CAR T-cell therapy. Gain a deeper understanding of the complexities surrounding this innovative treatment on Intention to Treat: https://nej.md/itt-ep29 | The New England Journal of Medicine | Facebook
Facebook2 weeks ago
Top videos
Electronic Submission of Adverse Event Reports to FDA FAERS
Electronic Submission of Adverse Event Reports to FDA FAERS
fda.gov
Apr 28, 2019
Establishment Registration– DRLS Workshop 2020
1:15:25
Establishment Registration– DRLS Workshop 2020
YouTubeU.S. Food and Drug
6.8K viewsNov 10, 2020
Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16-17, 2019
26:11
Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16-17, 2019
YouTubeU.S. Food and Drug
4.2K viewsApr 6, 2020
Center for Drug Evaluation and Research Drug Safety
Clinical Research, Drug Safety and Pharmacovigilance
Clinical Research, Drug Safety and Pharmacovigilance
aaps.ca
Nov 11, 2024
WATCH: Dr. Peter Marks, Director, Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration joins Pat to chat about the development of PPMD’s Dystrophinopathy Clinical Research Network (DCRN), and the need for a better understanding of long-term safety, efficacy, potential risks and benefits of add-on therapies in this growing landscape of approved and investigational therapies for #Duchenne. Stay tuned to learn more about PPMD’s plans for the DCRN and how inno
5:14
WATCH: Dr. Peter Marks, Director, Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration joins Pat to chat about the development of PPMD’s Dystrophinopathy Clinical Research Network (DCRN), and the need for a better understanding of long-term safety, efficacy, potential risks and benefits of add-on therapies in this growing landscape of approved and investigational therapies for #Duchenne. Stay tuned to learn more about PPMD’s plans for the DCRN and how inno
FacebookParent Project Muscular
2K viewsDec 5, 2024
Frank Pallone Urges Legislators Not To 'Lower The Bar For Sunscreen Safety' Ahead Of Summer Months
4:53
Frank Pallone Urges Legislators Not To 'Lower The Bar For Sunscreen Safety' Ahead Of Summer Months
MSNDailymotion
6 months ago
Electronic Submission of Adverse Event Reports to FDA FAERS
Electronic Submission of Adverse Event Reports to FDA FAERS
Apr 28, 2019
fda.gov
Establishment Registration– DRLS Workshop 2020
1:15:25
Establishment Registration– DRLS Workshop 2020
6.8K viewsNov 10, 2020
YouTubeU.S. Food and Drug Administration
Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16-17, 2019
26:11
Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16 …
4.2K viewsApr 6, 2020
YouTubeU.S. Food and Drug Administration
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1
Advancing Generic Drug Development: Translating Scienc…
1.1K viewsOct 6, 2023
YouTubeU.S. Food and Drug Administration
CDER Export Certificate Program - REdI 2020
CDER Export Certificate Program - REdI 2020
1.3K viewsAug 31, 2020
YouTubeU.S. Food and Drug Administration
FDA/CDER’s Small Business and Industry Assistance (SBIA) Program
1:27
FDA/CDER’s Small Business and Industry Assistance (SBIA) Program
9K viewsApr 17, 2017
YouTubeU.S. Food and Drug Administration
CDER Small Business and Industry Assistance Overview (12of14) REdI 2018
CDER Small Business and Industry Assistance Overview (12of14) REd…
3.3K viewsMay 15, 2020
YouTubeU.S. Food and Drug Administration
27:21
Digital IND Safety Reporting - Pharmacovigilance 2020
3.1K viewsJun 16, 2020
YouTubeU.S. Food and Drug Administration
9:28
Medical Device Regulations / FDA Approval
39.9K viewsJul 16, 2020
YouTubeThe BME Life
48:21
FDA Adverse Event Reporting System (FAERS) Overview - Phar…
9.6K viewsJun 15, 2020
YouTubeU.S. Food and Drug Administration
55:59
Submitting IND Safety Reports to FDA Adverse Event Reporting Sys…
10.8K viewsJan 17, 2020
YouTubeU.S. Food and Drug Administration
1:03:12
A Glance at Drug Importation Requirements
5.4K viewsJan 22, 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
52:33
FDA Drug Manufacturing Inspections - REdI 2020
10.1K viewsAug 31, 2020
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
20:33
ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Pers…
7.7K viewsMar 11, 2021
YouTubeU.S. Food and Drug Administration
46:00
Introduction to Investigational New Drug (IND) Applications (3/14) REd…
24.7K viewsAug 6, 2020
YouTubeU.S. Food and Drug Administration
3:44
FDA CDER Regulatory Science: The Importance of Partnership and Co…
2.2K viewsNov 16, 2017
YouTubeU.S. Food and Drug Administration
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
17:04
Calculating Maximum Daily Dose (MDD) for Orally Administered Dru…
17.1K viewsNov 24, 2020
YouTubeU.S. Food and Drug Administration
40:53
Submit Your Investigational New Drug (IND) Application and Clinica…
6.7K viewsAug 6, 2020
YouTubeU.S. Food and Drug Administration
54:28
Overview of Non-clinical Assessment in Drug Developmen…
18.7K viewsAug 6, 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
21:57
Biopharmaceutics Risk Assessment to Guide Dissolution Method Deve…
4.2K viewsMay 13, 2021
YouTubeU.S. Food and Drug Administration
See more videos
Static thumbnail place holder