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2020 CDER Small Business and Industry Assistance Webinars & Conferences
by U.S. Food and Drug Administration
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163 videos
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26,526 views
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2020 CDER Small Business and Industry Assistance Webinars & Conferences
163
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26,526 views
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Dec 7, 2020
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U.S. Food and Drug Administration
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Play all
2020 CDER Small Business and Industry Assistance Webinars & Conferences
by U.S. Food and Drug Administration
Playlist
•
163 videos
•
26,526 views
Play all
1
53:49
53:49
Now playing
Learn About ClinicalTrials.gov Modernization and How to Provide Input – Mar. 6, 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
6.9K views
•
4 years ago
•
2
1:24:58
1:24:58
Now playing
Updates on FDA’s Drug-Drug Interaction Final Guidances
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.6K views
•
4 years ago
•
3
59:01
59:01
Now playing
Postmarketing Drug Safety Compliance: 2019 Inspection Findings
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.2K views
•
4 years ago
•
4
45:13
45:13
Now playing
Conducting Clinical Trials During the COVID-19 Public Health Emergency
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.6K views
•
4 years ago
•
5
22:14
22:14
Now playing
Keynote: Generic Drug Program Update (1of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.8K views
•
4 years ago
•
6
21:09
21:09
Now playing
Keynote from the Office of Pharmaceutical Quality (OPQ) (2of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
865 views
•
4 years ago
•
7
40:35
40:35
Now playing
Product Specific Guidances (PSGs) (3of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
4 years ago
•
8
37:25
37:25
Now playing
Generic Drug Labeling: Recommendations for High-Quality Submissions (4of28) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.6K views
•
4 years ago
•
9
47:39
47:39
Now playing
New Programs and Requirements Under FDARA (5of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
4 years ago
•
10
35:52
35:52
Now playing
Pre-ANDA Interactions with the FDA (6of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
4 years ago
•
11
1:05:31
1:05:31
Now playing
Electronic Submission of an ANDA Application and Study Data (7of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.4K views
•
4 years ago
•
12
38:23
38:23
Now playing
ANDA Program Performance Review and Tips (8of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
4 years ago
•
13
1:06:01
1:06:01
Now playing
The Importance of Generic Drug Pharmacovigilance (9of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.7K views
•
4 years ago
•
14
1:13:26
1:13:26
Now playing
Current Global Generic Drug Landscape (10of16) Generic Drugs Forum
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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4.4K views
•
4 years ago
•
15
55:12
55:12
Now playing
ICH Q12 Guidance and Emerging Technology Program (11of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.7K views
•
4 years ago
•
16
57:58
57:58
Now playing
Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
6.8K views
•
4 years ago
•
17
52:07
52:07
Now playing
Common CMC (Quality) Issues and How to Avoid Them Part II (13of16) Generic Drugs Forum 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.2K views
•
4 years ago
•
18
47:42
47:42
Now playing
Generic Combination Products: Assessment and Regulatory Update (14of16) GDF 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.3K views
•
4 years ago
•
19
52:19
52:19
Now playing
Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15of16) GDF 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
5.4K views
•
4 years ago
•
20
45:22
45:22
Now playing
Application Case Studies on FDA’s Action Letter Timing (16of16) GDF 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
4 years ago
•
21
24:18
24:18
Now playing
Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead!
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.1K views
•
4 years ago
•
22
56:47
56:47
Now playing
Monograph reform is here! Learn what to expect and how to prepare.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
5.8K views
•
4 years ago
•
23
30:38
30:38
Now playing
Keynote – Pharmacovigilance and Risk Management Conference 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.8K views
•
4 years ago
•
24
22:45
22:45
Now playing
Process for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.3K views
•
4 years ago
•
25
46:22
46:22
Now playing
Best Practices for Proprietary Name Design – Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.8K views
•
4 years ago
•
26
47:15
47:15
Now playing
Designing User Interfaces to Prevent Medication Errors – Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.8K views
•
4 years ago
•
27
29:21
29:21
Now playing
Preventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.7K views
•
4 years ago
•
28
5:52
5:52
Now playing
Questions and Discussion – Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.8K views
•
4 years ago
•
29
41:06
41:06
Now playing
Division of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.7K views
•
4 years ago
•
30
37:41
37:41
Now playing
REMS Integration Initiatives - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.4K views
•
4 years ago
•
31
42:22
42:22
Now playing
Development of Shared System REMS & Implications of the Appropriations Act - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.9K views
•
4 years ago
•
32
38:16
38:16
Now playing
Considerations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.9K views
•
4 years ago
•
33
48:21
48:21
Now playing
FDA Adverse Event Reporting System (FAERS) Overview - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.3K views
•
4 years ago
•
34
27:21
27:21
Now playing
Digital IND Safety Reporting - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.9K views
•
4 years ago
•
35
23:33
23:33
Now playing
Combination Products: Reporting Device Information and Malfunctions - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.5K views
•
4 years ago
•
36
34:57
34:57
Now playing
ICSR Data Quality of Coding: Products, Adverse Events and Medication Errors - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.7K views
•
4 years ago
•
37
56:41
56:41
Now playing
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
5.1K views
•
4 years ago
•
38
54:27
54:27
Now playing
FDA's Sentinel Initiative - Pharmacovigilance 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.3K views
•
4 years ago
•
39
1:22:30
1:22:30
Now playing
CDER SEND Common Issues and Policy Update
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3K views
•
4 years ago
•
40
7:02
7:02
Now playing
Keynote - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
4 years ago
•
41
24:30
24:30
Now playing
Bioanalytical Method Validation: History, Process, and Regulatory Perspectives - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
6.6K views
•
4 years ago
•
42
20:09
20:09
Now playing
Regulated Bioanalysis of Large Molecules - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.9K views
•
4 years ago
•
43
13:55
13:55
Now playing
Regulated Bioanalysis for Small Molecules - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.2K views
•
4 years ago
•
44
16:21
16:21
Now playing
Panel Discussion - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
4 years ago
•
45
21:10
21:10
Now playing
Office of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.8K views
•
4 years ago
•
46
25:07
25:07
Now playing
Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
4 years ago
•
47
19:20
19:20
Now playing
Office of Clinical Pharmacology (OCP): Panel Discussion - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
630 views
•
4 years ago
•
48
16:23
16:23
Now playing
Bioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
741 views
•
4 years ago
•
49
17:53
17:53
Now playing
Common Deficiencies for Study Sample Reanalysis in PK BE for ANDAs - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
4 years ago
•
50
19:11
19:11
Now playing
Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
4 years ago
•
51
22:39
22:39
Now playing
Office of Generic Drugs Panel Discussion - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
855 views
•
4 years ago
•
52
15:31
15:31
Now playing
Overview of Immunogenicity Inspections - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
4 years ago
•
53
14:23
14:23
Now playing
Considerations on ex vivo Conversion of Prodrugs during Bioanalysis - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
776 views
•
4 years ago
•
54
15:39
15:39
Now playing
Bioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis '20
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
4 years ago
•
55
16:28
16:28
Now playing
What Meta-analysis Can Tell You about the Performance of Bioanalytical Methods - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
626 views
•
4 years ago
•
56
7:38
7:38
Now playing
CREST Site Selection Model Overview - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
373 views
•
4 years ago
•
57
17:17
17:17
Now playing
Office of Study Integrity and Surveillance Session (OSIS) Panel Discussion - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
469 views
•
4 years ago
•
58
26:11
26:11
Now playing
Case Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection - Bioanalysis 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
910 views
•
4 years ago
•
59
11:36
11:36
Now playing
Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.2K views
•
4 years ago
•
60
11:14
11:14
Now playing
An International Commitment to Pharmaceutical Quality (2/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
775 views
•
4 years ago
•
61
21:11
21:11
Now playing
Manufacturing Assessment and Application Action (3/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1K views
•
4 years ago
•
62
14:24
14:24
Now playing
Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.8K views
•
4 years ago
•
63
19:31
19:31
Now playing
An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
4 years ago
•
64
27:20
27:20
Now playing
Panel Discussion (6/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
405 views
•
4 years ago
•
65
18:59
18:59
Now playing
FDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
481 views
•
4 years ago
•
66
20:13
20:13
Now playing
Quality Management Maturity: FDA Vision & Expectations (8/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.5K views
•
4 years ago
•
67
20:06
20:06
Now playing
Major Issues and Facilities in Drug Master Files (9/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.9K views
•
4 years ago
•
68
19:16
19:16
Now playing
Pharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.1K views
•
4 years ago
•
69
17:48
17:48
Now playing
Panel Discussion (11/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
292 views
•
4 years ago
•
70
10:55
10:55
Now playing
FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
816 views
•
4 years ago
•
71
15:00
15:00
Now playing
The State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
600 views
•
4 years ago
•
72
20:10
20:10
Now playing
Successfully Implementing Advanced Manufacturing (14/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
941 views
•
4 years ago
•
73
19:51
19:51
Now playing
Panel Discussion (15/15) Global Quality
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
360 views
•
4 years ago
•
74
40:32
40:32
Now playing
Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
6.4K views
•
4 years ago
•
75
49:07
49:07
Now playing
Restructure of the Office of New Drugs (OND) - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
955 views
•
4 years ago
•
76
58:43
58:43
Now playing
So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4.5K views
•
4 years ago
•
77
35:16
35:16
Now playing
Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
6.4K views
•
4 years ago
•
78
40:46
40:46
Now playing
Drug Shortages - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
951 views
•
4 years ago
•
79
38:38
38:38
Now playing
Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.1K views
•
4 years ago
•
80
37:27
37:27
Now playing
CDER Export Certificate Program - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
4 years ago
•
81
18:10
18:10
Now playing
SBIA Program Overview - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.4K views
•
4 years ago
•
82
29:45
29:45
Now playing
Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
4K views
•
4 years ago
•
83
1:07:10
1:07:10
Now playing
Requirement for Electronic Submission of an Application and Study Data - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.7K views
•
4 years ago
•
84
27:10
27:10
Now playing
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
8.7K views
•
4 years ago
•
85
34:37
34:37
Now playing
Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.8K views
•
4 years ago
•
86
28:11
28:11
Now playing
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
13K views
•
4 years ago
•
87
30:07
30:07
Now playing
Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2K views
•
4 years ago
•
88
52:33
52:33
Now playing
FDA Drug Manufacturing Inspections - REdI 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
9.2K views
•
4 years ago
•
89
1:00:06
1:00:06
Now playing
Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.1K views
•
4 years ago
•
90
1:22:14
1:22:14
Now playing
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
16K views
•
4 years ago
•
91
21:06
21:06
Now playing
Keynote: eDRLS and the COVID-19 Public Health Emergency – DRLS 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.3K views
•
4 years ago
•
92
50:56
50:56
Now playing
Labeler Code Request – DRLS Workshop 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.4K views
•
4 years ago
•
93
1:15:25
1:15:25
Now playing
Establishment Registration– DRLS Workshop 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
6.4K views
•
4 years ago
•
94
1:31:31
1:31:31
Now playing
Drug Listing – DRLS Workshop 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
3.2K views
•
4 years ago
•
95
32:20
32:20
Now playing
503B Compounder Product Reporting using CDER Direct – DRLS Workshop 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
4 years ago
•
96
1:48:21
1:48:21
Now playing
Establishment Registration and Drug Listing Compliance Program – DRLS Workshop 2020
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
11K views
•
4 years ago
•
97
41:57
41:57
Now playing
Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available (1 of 2)
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.6K views
•
4 years ago
•
98
52:22
52:22
Now playing
Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available (2 of 2)
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
1.2K views
•
4 years ago
•
99
20:31
20:31
Now playing
FDA Announces Quality Management Maturity Programs
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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2K views
•
4 years ago
•
100
1:56:00
1:56:00
Now playing
Promoting Safe and Effective Prescription Drug Use in Geriatric Patients
U.S. Food and Drug Administration
U.S. Food and Drug Administration
•
2.9K views
•
4 years ago
•