FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines - September 27, 2022 Published 2022-11-02 Download video MP4 360p Recommendations 43:54 FDA Drug Topics: Reporting and Public Viewing of Individual Case Safety Reports (ICSRs) May 24, 2022 1:19:35 Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018 22:52 ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues 8:05:24 Advancing Generic Drugs Development: Translating Science to Approval 2023 - Day 1 03:29 How Does The FDA Approve New Drugs? 7:58:37 Advancing Generic Drugs Development: Translating Science to Approval 2023 - Day 2 1:48:54 2022 FDA Virtual Digital Transformation Symposium – Day 2 Afternoon Session 40:34 Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3of14) REdI '18 8:02:40 182nd Meeting of Vaccines and Related Biological Products Advisory Committee 02:21 What does the FDA do after drugs are approved? 02:02 5 Things You Need to Know About the Drug Approval Process 7:49:25 September 13, 2023 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) 28:51 Overview of Warning Letters for Online Retailers 02:28 What is FDA’s role in regulating drugs? 53:25 OTC Monograph Reform: OMOR Format and Content & Electronic Submissions 3:27:43 September 11-12, 2023 Meeting of the Nonprescription Drugs Advisory Committee (NDAC) - Day 2 4:23:03 Listening Session: Developing FDA’s Center for Tobacco Products’ Strategic Plan (Aug. 22, 2023) 8:29:05 FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Devices Day 2/Biologics Day 1 01:01 From Mammograms to Microwaves | Researching FDA Similar videos 7:46:19 FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Drugs Day 2 54:29 FDA Drug Topics Understanding Generic Narrow Therapeutic Index Drugs November 1, 2022 8:03:06 FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Biologics Day 2 7:42:41 FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Plenary + Drugs Day 1 56:25 Overview: Clinical Pharmacology Considerations for Neonatal Studies 9:05:54 178th Meeting of Vaccines and Related Biological Products Advisory Committee – 1/26/2023 55:40 Nonprescription Drug Product with an Additional Condition for Nonprescription Use 8:43:25 181st Meeting of the Vaccines and Related Biological Products Advisory Committee 4:12:45 Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines - Day 2 6:32:04 180th Meeting of Vaccines and Related Biological Products Advisory Committee 7:31:34 FDA Regulatory Education for Industry (REdI) – Biologics Track 8:21:29 November 9, 2022 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) 7:23:57 November 16, 2022 Meeting of the Cardiovascular and Renal Drugs Advisory Committee 8:42:55 Vaccines and Related Biological Products Advisory Committee – 6/28/2022 6:35:41 November 8, 2022 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) 2:59:15 FDA Webinar on the Food Traceability Final Rule 5:16:51 February 10, 2022 Meeting of the Oncologic Drugs Advisory Committee (ODAC) More results