Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 Published 2020-08-06 Download video MP4 360p Recommendations 40:53 Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017 46:00 Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 44:31 Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018 1:20:20 Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017 1:19:35 Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018 1:22:14 Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs 29:42 CMC Considerations for CAR T Cell Product Development 39:09 Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017 33:18 Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018 05:47 How Biomarkers Can Improve the Drug Development Process 29:20 FDA Oncology Drug Development Overview – Past to Present 28:11 Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 37:34 Designing First-In-Human Trials for Small Molecules and Biologics 05:33 Biomarker Terminology: Speaking the Same Language 40:47 Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 8:28:56 FDA-MHRA-HC 2024 Joint Symposium (Day 3) 46:52 Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective 46:23 Electronic Common Technical Document (eCTD) 1:25:18 FDA Clinical Investigator Training Course (CITC) 2022, Day 2 – Part 2 7:06:50 FDA-MHRA-HC 2024 Joint Symposium (Day 1) Similar videos 40:24 FDA Communication During Drug Development (4/14) REdI 2017 40:26 Benefit-Risk Considerations During Drug Product Development (8of14) REdI 2018 37:56 Regulatory and Administrative Components of an IND Application (5/14) REdI 2017 36:51 Investigational New Drug Safety Reporting Requirements (10of14) REdI 2018 40:34 Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3of14) REdI '18 33:24 Wojciech Jankowski: Non-clinical Assessments of Immunogenicity 1:13:47 Optimizing Your Study Data Submissions to FDA: Study Data TCG – Nov. 8, 2017 1:27:09 Overview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9) Labeling 2017 55:56 Drug Development after IND: what happens next? 1:30:59 Drug development and clinical trials 101 1:14:55 Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017 46:06 [Safety] S9 2:03:01 Investigational New Drug Workshop 06:07 Keynote Overview – CDER Compliance Conference 25:07 CDER Small Business and Industry Assistance Overview (12of14) REdI 2018 More results