Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018

Published 2020-05-15

Recommendations

40:26

Benefit-Risk Considerations During Drug Product Development (8of14) REdI 2018
1:20:20

Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
33:18

Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
44:31

Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
1:02:19

Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.
28:11

Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
46:00

Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017
1:56:22

FDA Clinical Investigator Training Course (CITC) 2023, Day 1 – Part 1
22:54

An Introduction to FDA's Regulation of Medical Devices
1:10:48

CMC - NDA requirements and Common Pitfalls of BLAs (14of15) REdI – May 29-30, 2019
2:03:33

A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
1:22:14

Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
1:02:25

FDA New Era of Smarter Food Safety Tech-Enabled Traceability Video Series: Supply Chain Technology
1:30:38

Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations
34:37

Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020
54:28

Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
29:42

CMC Considerations for CAR T Cell Product Development
46:23

Electronic Common Technical Document (eCTD)
05:47

How Biomarkers Can Improve the Drug Development Process
57:58

Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum

Similar videos