Investigational New Drug (IND) Applications: What You Need to Know for Successful Interactions with the FDA
Presented by: NIH Clinical CenterCategory: NIH OnlyAired date: 12/12/2013 (Source: Videocast - All Events)
Source: Videocast - All Events - December 18, 2013 Category: Journals (General) Tags: Past Events Source Type: video
Investigational New Drug (IND) Applications: What You Need to Know for Successful Interactions with the FDA
An educational program of the NIH Clinical Center-FDA CDER Joint Task Force emphasizing regulatory requirements for clinical trials of new and repurposed drugs, with a special focus on rare diseases.
Target Audience:
Clinical investigators, clinical research study coordinators, clinical and translational research scientists and trainees.
Objectives:
• To provide training in FDA regulations for NIH investigators involved in phase I and phase II clinical trials of investigational drugs, emphasizing safety considerations in the early phases of drug development.
• To describe the IND-enabling elements of non-clin...
Source: Videocast - All Events - November 7, 2013 Category: Journals (General) Tags: Upcoming Events Source Type: video
