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Expedited Categories Presentations

Expedited Categories Overview 09.2022

Expedited Categories 2 and 3 10.2022

Categories 2 and 3 Presentation Recording

Expedited Category 4 10.2022

Category 4 w/ Review of 2 and 3 Presentation Recording

Expedited Categories 5 6 7 09.2022

Expedited Categories 8 and 9 10.10.2022

 Categories 8 and 9 Presentation Recording

 

Exempt Categories Presentations

Exempt Category 1 08.2022

Category 1 Annotated Application

Exempt Categories 2 and 3 08.2022

Category 2 & 3 Annotated Application

Exempt Category 4 08.2022

Category 4 Annotated Application

 

 

Not Human Subjects Research

NHSR Slides

NHSR Presentation Recording

 

 

Q&A Session, October 24, 2022

Recording

 

FDA Overview

FDA Training Drugs 11/21/22

FDA  Recording 11/21/2022

FDA Case Studies Presentation Recording 12/5/2022

FDA Presentation Recording 12/8/2022

FDA Device Case Studies Presentation Recording 1/23/2023

FDA Device Case Studies PowerPoint