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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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23,706 views
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2021 CDER Small Business and Industry Assistance Webinars & Conferences
208
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23,706 views
Last updated on
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
•
23,706 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
•
3.3K 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
•
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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4.6K 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
•
796 views
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3 years ago
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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
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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
•
872 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
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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
•
3.1K 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
•
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
•
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
•
477 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
•
821 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
•
359 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
•
830 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
•
302 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
•
635 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
•
571 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
•
3.4K 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
•
504 views
•
3 years ago
•
45
40:14
40:14
Now playing
Product Quality Consideration for Emergency Use Authorizations (EUAs)
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
847 views
•
3 years ago
•
46
46:23
46:23
Now playing
Electronic Common Technical Document (eCTD)
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
12K views
•
3 years ago
•
47
22:17
22:17
Now playing
CDER NextGen Portal
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.4K views
•
3 years ago
•
48
29:10
29:10
Now playing
Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
251 views
•
3 years ago
•
49
4:21
4:21
Now playing
ANDA Efforts Related to COVID-19
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
395 views
•
3 years ago
•
50
41:25
41:25
Now playing
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
1:09:45
1:09:45
Now playing
Plenary Session
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
619 views
•
3 years ago
•
52
18:56
18:56
Now playing
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
1:14:28
1:14:28
Now playing
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
4:18
4:18
Now playing
Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
677 views
•
3 years ago
•
55
1:16:01
1:16:01
Now playing
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
1:33:54
1:33:54
Now playing
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
32:50
32:50
Now playing
Complex Product Characterization/Analysis - Session 2B
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
3 years ago
•
58
34:41
34:41
Now playing
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
1:01:02
1:01:02
Now playing
Model-Integrated Evidence for Generic Drug Development – Session 1C
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
683 views
•
3 years ago
•
60
50:27
50:27
Now playing
Model-Integrated Evidence for Generic Drug Development – Session 1B
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
3 years ago
•
61
50:54
50:54
Now playing
Model-Integrated Evidence for Generic Drug Development – Session 1A
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
564 views
•
3 years ago
•
62
53:19
53:19
Now playing
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
20:39
20:39
Now playing
Public Comment - GDUFA Science and Research Initiatives Public Workshop
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
423 views
•
3 years ago
•
64
1:22:09
1:22:09
Now playing
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
1:21:44
1:21:44
Now playing
Keynote and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
785 views
•
3 years ago
•
66
35:38
35:38
Now playing
Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.8K views
•
3 years ago
•
67
1:27:00
1:27:00
Now playing
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
7:31:34
7:31:34
Now playing
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
8:58:15
8:58:15
Now playing
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
7:31:31
7:31:31
Now playing
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
49:29
49:29
Now playing
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
21:18
21:18
Now playing
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
12:57
12:57
Now playing
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
1:26:22
1:26:22
Now playing
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.7K views
•
3 years ago
•
75
1:03:29
1:03:29
Now playing
FDA and Health Canada Regional ICH Consultation Part II
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
941 views
•
3 years ago
•
76
1:29:33
1:29:33
Now playing
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
4:55
4:55
Now playing
Product Specific Guidances - Closing Remarks
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
207 views
•
3 years ago
•
78
17:43
17:43
Now playing
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
55:25
55:25
Now playing
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
1:02:16
1:02:16
Now playing
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
19:15
19:15
Now playing
Bioequivalence Regulations and Product-Specific Guidances
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.3K views
•
3 years ago
•
82
21:11
21:11
Now playing
Developing and Implementing Science-Based Standards in Bioequivalence Assessment
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
810 views
•
3 years ago
•
83
14:41
14:41
Now playing
Product-Specific Guidance Fundamentals from a Clinical Perspective
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
668 views
•
3 years ago
•
84
19:10
19:10
Now playing
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
20:00
20:00
Now playing
Non-Complex Drug Products and Product-Specific Guidances
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
770 views
•
3 years ago
•
86
13:21
13:21
Now playing
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
30:56
30:56
Now playing
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
258 views
•
3 years ago
•
88
22:52
22:52
Now playing
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
•
5.2K views
•
3 years ago
•
89
15:11
15:11
Now playing
Update on Shared System REMS for Generic Drugs
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
783 views
•
3 years ago
•
90
24:08
24:08
Now playing
Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
712 views
•
3 years ago
•
91
14:52
14:52
Now playing
Postmarketing Safety and Surveillance of Generic Drugs Update
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
3 years ago
•
92
30:18
30:18
Now playing
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
337 views
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3 years ago
•
93
23:39
23:39
Now playing
Building a Better Sterility Assurance Application
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
768 views
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3 years ago
•
94
22:47
22:47
Now playing
Integrated Manufacturing Assessment: Expectations
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
378 views
•
3 years ago
•
95
21:57
21:57
Now playing
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
24:45
24:45
Now playing
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
336 views
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3 years ago
•
97
31:55
31:55
Now playing
Assessment of Extractables/Leachables Data in ANDA Submissions
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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8.3K views
•
3 years ago
•
98
19:58
19:58
Now playing
Lab Science to Support Generic Complex Drug Product Assessment
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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310 views
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3 years ago
•
99
15:15
15:15
Now playing
Fostering Innovation Through OPQ’s Emerging Technology Program
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
133 views
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3 years ago
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100
18:40
18:40
Now playing
Panel Discussion
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
144 views
•
3 years ago
•
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