Framework for FDA’s Real-World Evidence Program – Mar 15, 2019 Published 2019-11-26 Download video MP4 360p Download video MP4 720p Recommendations 26:05 The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs – June 17, 2019 40:32 Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020 1:28:43 Modeling and Simulation to Select Oncology Dosages - Session 1 43:23 FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products- June 10, 2019 03:18 50th Biosimilar, Anti-choking Devices, New Initiative, High Blood Pressure | FDA In Your Day Ep. 4 55:56 Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI – May 29-30, 2019 1:23:58 Statistical Considerations for Premarketing Risk Assessment 6:01:40 May 22, 2024 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee 1:07:57 Promotional Submissions in eCTD Format: Common Errors and Validations – Oct. 25, 2019 1:14:28 Navigating the World of Combination Products (2of15) REdI – May 29-30, 2019 42:43 Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019 32:49 Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections–6/17/19 01:36 How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA 5:21:05 125th Meeting of the Blood Products Advisory Committee (BPAC) 56:41 Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020 2:31:56 Modeling and Simulation to Select Oncology Dosages - Session 3 38:21 NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019 01:27 Dr. Matthew Hahn on Treating OUD with Medication 1:00:50 CDER FDA Exclusivity – Which One Is for Me? - June 10, 2019 42:14 Accuracy and Precision in Bioanalysis: Review of Case Studies – June 17, 2019 Similar videos 1:02:25 Webinar: Let's Get Real: How Will the FDA Framework for Real-World Evidence Impact You? 03:19 Real-World Evidence in Regulatory Decision-Making 27:06 MDUFA IV: Accessing and Using Real-World and Postmarket Data for Regulatory Decision-Making 18:13 Introduction To Real-World Evidence 02:01 Using Real-World Data for FDA Regulatory Decision-Making 1:02:24 Webinar: What’s the Reality of Real World Evidence? 53:51 The Role of Real World Evidence in Regulatory Decision Making 02:31 What is Real-World Evidence? 49:17 Real-World Evidence: How Big Data is Changing Scientific Standards 10:59 DIA 2019: Advancing the Use of Real World Evidence for Regulatory Decision Making 5:50:38 Real World Evidence Conference #Part1 - English version 21:39 Real world evidence in clinical trials 31:18 FDA RWE Regulatory Perspective 18:15 Real-world Evidence and Regulatory Submissions 19:58 CDER Industry Assistance Resources (13of15) REdI – May 29-30, 2019 34:44 Real-World Evidence is Changing Medicine - Part 3 59:29 Case Examples of Patient Centered Real World Evidence More results