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
1:19:35
Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
40:34
Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3of14) REdI '18
55:56
Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI – May 29-30, 2019
41:00
FDA Regulatory Requirements for Clinical Investigators and Case Examples (9of14) REdI 2018
20:08
505(b)(2) NDA or ANDA? (10of28) Generic Drugs Forum – Apr. 3-4, 2019
29:42
CMC Considerations for CAR T Cell Product Development
32:21