ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities Published 2023-08-08 Download video MP4 360p Download video MP4 720p Recommendations 12:18 ClinicalTrials.gov: Part 1 - Meeting Transparency and Reporting Requirements 15:33 ClinicalTrials.gov: Part 2 - Definitions, Laws, and Regulations 57:01 Decentralized Clinical Trials (DCT) Draft Guidance 53:25 OTC Monograph Reform: OMOR Format and Content & Electronic Submissions 1:48:54 2022 FDA Virtual Digital Transformation Symposium – Day 2 Afternoon Session 03:17 How does the FDA approve new drugs? 28:51 Overview of Warning Letters for Online Retailers 00:53 Science is our Business! 02:28 What is FDA’s role in regulating drugs? 3:27:43 September 11-12, 2023 Meeting of the Nonprescription Drugs Advisory Committee (NDAC) - Day 2 00:38 Three Vaccines are Now Available for Fall/Winter Respiratory Illnesses 02:21 What does the FDA do after drugs are approved? 7:58:37 Advancing Generic Drugs Development: Translating Science to Approval 2023 - Day 2 8:05:24 Advancing Generic Drugs Development: Translating Science to Approval 2023 - Day 1 01:01 From Mammograms to Microwaves | Researching FDA 4:23:03 Listening Session: Developing FDA’s Center for Tobacco Products’ Strategic Plan (Aug. 22, 2023) 7:49:25 September 13, 2023 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) 37:06 Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine - 4/13/2021 01:14 At-Home COVID-19 Test Resources 8:22:00 September 11-12, 2023 Meeting of the Nonprescription Drugs Advisory Committee (NDAC) - Day 1 Similar videos 2:25:17 CDER BIMO GCP Compliance and Enforcement 06:07 Keynote Overview – CDER Compliance Conference 04:43 Welcome from CDER’s Office of Compliance (1of8) Registration and Listing - Oct. 22, 2019 1:07:11 2019 CCTS FDA Conference - CDER BIMO Compliance and Enforcement 52:19 Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15of16) GDF 2020 1:10:40 BIMO, REMS, and PADE Inspection Readiness (3of3) Jun. 19, 2018 41:00 FDA Regulatory Requirements for Clinical Investigators and Case Examples (9of14) REdI 2018 57:37 Risk Evaluation and Mitigation Strategies (REMS) Compliance Program 1:17:23 FDA Guidance on Manufacturing During COVID-19 and High Absenteeism 59:01 Postmarketing Drug Safety Compliance: 2019 Inspection Findings 31:16 FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency 2:11:32 Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 3 40:47 Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 1:00:06 Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations 1:18:00 Regulatory Education for Industry (REdI) Annual Conference 2023 – Day 2 – Session 4 and Closing More results