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2021 CDER Small Business and Industry Assistance Webinars & Conferences
by U.S. Food and Drug Administration
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208 videos
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23,640 views
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2021 CDER Small Business and Industry Assistance Webinars & Conferences
208
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23,640 views
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Jul 11, 2024
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Play all
2021 CDER Small Business and Industry Assistance Webinars & Conferences
by U.S. Food and Drug Administration
Playlist
•
208 videos
•
23,640 views
Play all
1
42:44
42:44
Now playing
OTC Monograph Reform: OTC Sunscreen Drugs
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4K views
•
3 years ago
•
2
47:40
47:40
Now playing
OTC Monograph Reform: Deemed Final Orders
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.2K views
•
3 years ago
•
3
1:27:24
1:27:24
Now playing
Clinical Investigator Training Course (CITC) Update - Operational Updates Part 2
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
3 years ago
•
4
1:48:00
1:48:00
Now playing
Clinical Investigator Training Course (CITC) Update - Operational Updates Part 1
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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1.6K views
•
3 years ago
•
5
1:23:07
1:23:07
Now playing
Clinical Investigator Training Course (CITC) Update - Scientific Updates Part 1
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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4.5K views
•
3 years ago
•
6
1:33:32
1:33:32
Now playing
Pharmaceutical Quality Symposium 2021 Part 8 with Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
792 views
•
3 years ago
•
7
54:52
54:52
Now playing
Pharmaceutical Quality Symposium 2021 Part 7
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
920 views
•
3 years ago
•
8
54:19
54:19
Now playing
Pharmaceutical Quality Symposium 2021 Part 6
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
870 views
•
3 years ago
•
9
1:52:12
1:52:12
Now playing
Pharmaceutical Quality Symposium 2021 Part 5
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.9K views
•
3 years ago
•
10
1:25:57
1:25:57
Now playing
Pharmaceutical Quality Symposium 2021 Part 4
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
3 years ago
•
11
1:39:46
1:39:46
Now playing
Pharmaceutical Quality Symposium 2021 Part 3
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.3K views
•
3 years ago
•
12
1:03:51
1:03:51
Now playing
Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.8K views
•
3 years ago
•
13
1:58:48
1:58:48
Now playing
Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
5.4K views
•
3 years ago
•
14
1:47:29
1:47:29
Now playing
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 and Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3K views
•
3 years ago
•
15
1:09:21
1:09:21
Now playing
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.1K views
•
3 years ago
•
16
1:50:51
1:50:51
Now playing
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.5K views
•
3 years ago
•
17
1:24:08
1:24:08
Now playing
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.9K views
•
3 years ago
•
18
1:26:42
1:26:42
Now playing
Enhanced Drug Distribution Security in 2023 Under the DSCSA
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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5.6K views
•
3 years ago
•
19
21:20
21:20
Now playing
Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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2.3K views
•
3 years ago
•
20
6:06
6:06
Now playing
Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
3 years ago
•
21
1:31:52
1:31:52
Now playing
Complex Generics: Topical Products, Part 2
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2K views
•
3 years ago
•
22
1:57:52
1:57:52
Now playing
Complex Generics: Topical Products, Part 1
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.2K views
•
3 years ago
•
23
1:51:52
1:51:52
Now playing
Complex Generics: Nasal and Inhalation Products
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.3K views
•
3 years ago
•
24
1:59:34
1:59:34
Now playing
Cutting Edge Science in Complex Generics
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
3 years ago
•
25
6:07
6:07
Now playing
Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
472 views
•
3 years ago
•
26
1:29:24
1:29:24
Now playing
Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 2
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.1K views
•
3 years ago
•
27
1:25:59
1:25:59
Now playing
Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 1
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.4K views
•
3 years ago
•
28
1:47:25
1:47:25
Now playing
Considerations in Assessing Generic Drug Products of Oral Dosage Forms
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.4K views
•
3 years ago
•
29
1:48:13
1:48:13
Now playing
COVID-19 Impact on Generic Drug Regulation and Evaluation
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
3 years ago
•
30
9:06
9:06
Now playing
Advancing Generic Drug Development: Translating Science to Approval Keynote Address
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
818 views
•
3 years ago
•
31
57:18
57:18
Now playing
Promotional Submissions in eCTD Format - Grouped Submissions
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.1K views
•
3 years ago
•
32
1:21:45
1:21:45
Now playing
Inspections and Use of Alternate Tools During the COVID-19 Public Health Emergency + Q/A Panel
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
3 years ago
•
33
1:17:33
1:17:33
Now playing
Risk Management and Application Approaches in Responding to Supply Chain Constraints During PHE
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
3 years ago
•
34
1:17:23
1:17:23
Now playing
FDA Guidance on Manufacturing During COVID-19 and High Absenteeism
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.3K views
•
3 years ago
•
35
54:02
54:02
Now playing
OSI’s Role in the Drug Development Process and Impact of COVID-19
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.9K views
•
3 years ago
•
36
31:16
31:16
Now playing
FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2K views
•
3 years ago
•
37
38:56
38:56
Now playing
Role of the Product Jurisdiction Team in the Medical Product Development Process
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
351 views
•
3 years ago
•
38
26:21
26:21
Now playing
Regulatory Policy: Role in Guiding Decision Making in CDER
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
817 views
•
3 years ago
•
39
19:50
19:50
Now playing
Communications in a Global Pandemic
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
301 views
•
3 years ago
•
40
34:13
34:13
Now playing
Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
3 years ago
•
41
39:09
39:09
Now playing
Where Do We Go from Here? How the Ombudsman Can Help
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
626 views
•
3 years ago
•
42
1:18:40
1:18:40
Now playing
CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
567 views
•
3 years ago
•
43
37:46
37:46
Now playing
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.3K views
•
3 years ago
•
44
37:28
37:28
Now playing
Strategies to Address Potential Medication Errors for EUA Products for COVID-19
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
502 views
•
3 years ago
•
45
Product Quality Consideration for Emergency Use Authorizations (EUAs)
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
842 views
•
3 years ago
•
46
Electronic Common Technical Document (eCTD)
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
12K views
•
3 years ago
•
47
CDER NextGen Portal
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.3K views
•
3 years ago
•
48
Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
246 views
•
3 years ago
•
49
ANDA Efforts Related to COVID-19
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
393 views
•
3 years ago
•
50
OND Reorganization and the New Drugs Regulatory Program Modernization
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
3 years ago
•
51
Plenary Session
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
613 views
•
3 years ago
•
52
2021 REdI Conference Keynote Address by Janet Woodcock, MD
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
3 years ago
•
53
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.3K views
•
3 years ago
•
54
Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
667 views
•
3 years ago
•
55
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
3 years ago
•
56
Complex Product Characterization/Analysis - Session 2C
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
3 years ago
•
57
Complex Product Characterization/Analysis - Session 2B
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
3 years ago
•
58
Complex Product Characterization/Analysis - Session 2A
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.5K views
•
3 years ago
•
59
Model-Integrated Evidence for Generic Drug Development – Session 1C
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
675 views
•
3 years ago
•
60
Model-Integrated Evidence for Generic Drug Development – Session 1B
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
3 years ago
•
61
Model-Integrated Evidence for Generic Drug Development – Session 1A
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
561 views
•
3 years ago
•
62
Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
403 views
•
3 years ago
•
63
Public Comment - GDUFA Science and Research Initiatives Public Workshop
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
419 views
•
3 years ago
•
64
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
3 years ago
•
65
Keynote and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
784 views
•
3 years ago
•
66
Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.7K views
•
3 years ago
•
67
Identification of Medicinal Products: Path to Global Implementation
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.4K views
•
3 years ago
•
68
FDA Regulatory Education for Industry (REdI) – Biologics Track
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
9.7K views
•
Streamed 3 years ago
•
69
FDA Regulatory Education for Industry (REdI) – Devices and Biologics Track
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.2K views
•
Streamed 3 years ago
•
70
FDA Regulatory Education for Industry (REdI) – Devices Track
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
10K views
•
Streamed 3 years ago
•
71
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2K views
•
3 years ago
•
72
ANDA Labeling: Helpful Hints and Resources
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.7K views
•
3 years ago
•
73
Product Specific Guidances Webinar – Opening Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.1K views
•
3 years ago
•
74
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.6K views
•
3 years ago
•
75
FDA and Health Canada Regional ICH Consultation Part II
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
937 views
•
3 years ago
•
76
FDA and Health Canada Regional ICH Consultation Part I
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.8K views
•
3 years ago
•
77
Product Specific Guidances - Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
206 views
•
3 years ago
•
78
Controlled Correspondence Related to Pharmaceutical Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
3 years ago
•
79
Common Labeling Deficiencies and Tips for Generic Drug Applications
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3K views
•
3 years ago
•
80
Panel Discussion on Product-Specific Guidances
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
3 years ago
•
81
Bioequivalence Regulations and Product-Specific Guidances
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.2K views
•
3 years ago
•
82
Developing and Implementing Science-Based Standards in Bioequivalence Assessment
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
799 views
•
3 years ago
•
83
Product-Specific Guidance Fundamentals from a Clinical Perspective
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
659 views
•
3 years ago
•
84
Product-Specific Guidances for Complex Generic Drugs
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
3 years ago
•
85
Non-Complex Drug Products and Product-Specific Guidances
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
762 views
•
3 years ago
•
86
Overview of the FDA Product-Specific Guidance Program
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
3 years ago
•
87
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
256 views
•
3 years ago
•
88
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
5.1K views
•
3 years ago
•
89
Update on Shared System REMS for Generic Drugs
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
749 views
•
3 years ago
•
90
Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
703 views
•
3 years ago
•
91
Postmarketing Safety and Surveillance of Generic Drugs Update
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
3 years ago
•
92
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
337 views
•
3 years ago
•
93
Building a Better Sterility Assurance Application
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
756 views
•
3 years ago
•
94
Integrated Manufacturing Assessment: Expectations
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
373 views
•
3 years ago
•
95
Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.8K views
•
3 years ago
•
96
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
331 views
•
3 years ago
•
97
Assessment of Extractables/Leachables Data in ANDA Submissions
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.2K views
•
3 years ago
•
98
Lab Science to Support Generic Complex Drug Product Assessment
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
306 views
•
3 years ago
•
99
Fostering Innovation Through OPQ’s Emerging Technology Program
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
133 views
•
3 years ago
•
100
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
144 views
•
3 years ago
•