1.7K views · 16 reactions |  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 | Facebook
0:19
1.7K views · 16 reactions |  Listen in to learn about a recent FDA adv…
341 views3 weeks ago
FacebookU.S. Food and Drug Administration
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
Postmarketing Adverse Drug Experience (PADE) Inspections – (1of3) Jun. 19, 2018
1:03:54
Postmarketing Adverse Drug Experience (PADE) Inspections – (…
3.1K viewsApr 13, 2020
YouTubeU.S. Food and Drug Administration
Best Practices for Topical Generic Product Development and ANDA Submission–Introduction & Session 1
Best Practices for Topical Generic Product Development and ANDA …
2.7K viewsAug 25, 2022
YouTubeU.S. Food and Drug Administration
Jobs at FDA
Jobs at FDA
Apr 26, 2019
fda.gov
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) REd…
3.3K viewsMay 15, 2020
YouTubeU.S. Food and Drug Administration
1:00
FDA Website Refresh
2.7K viewsDec 7, 2011
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
25:57
Data Integrity Issues in Bioequivalence Studies
1.1K viewsMay 13, 2021
YouTubeU.S. Food and Drug Administration
46:23
Electronic Common Technical Document (eCTD)
13.2K viewsJul 29, 2021
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
55:59
Submitting IND Safety Reports to FDA Adverse Event Reporting Sys…
10.8K viewsJan 17, 2020
YouTubeU.S. Food and Drug Administration
57:37
Risk Evaluation and Mitigation Strategies (REMS) Compliance Pr…
15.3K viewsJan 22, 2021
YouTubeU.S. Food and Drug Administration
13:21
Overview of the FDA Product-Specific Guidance Program
1.7K viewsMay 14, 2021
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
6:24
FDA’s FREE CERTIFICATION COURSES - PHARMA PORTAL
33.7K viewsMay 28, 2020
YouTubePHARMA PORTAL
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
4.9K 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
12:11
Quality Management Systems and Quality By Design (3of11) GCP Dat…
3.5K viewsMay 18, 2020
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
46:00
Introduction to Investigational New Drug (IND) Applications (3/14) REd…
24.7K viewsAug 6, 2020
YouTubeU.S. Food and Drug Administration
24:05
Orange Book 101: An Overview of FDA's Orange Book
6.2K viewsNov 30, 2020
YouTubeU.S. Food and Drug Administration
53:09
503B Product Reporting for Compounding Outsourcing Faciliti…
3.8K viewsJul 24, 2020
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
46:52
Preclinical Considerations for Cell and Gene Therapy Products, an F…
18.6K viewsApr 15, 2021
YouTubeU.S. Food and Drug Administration
17:04
Calculating Maximum Daily Dose (MDD) for Orally Administered Dru…
16.8K viewsNov 24, 2020
YouTubeU.S. Food and Drug Administration
See more videos
Static thumbnail place holder