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INDs: When Required and Contents

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Louise666

An introduction intended for professionals who are not familiar with Investigational New Drug applications.

1 of 58
Louise Johnson, M.S. INVESTIGATIONAL NEW DRUG APPLICATION (IND) Requirements for Filing and Contents of Submission The Bio2Device Group May 18, 2010
What is an IND, its benefits, & your responsibilities as a sponsor? ,[object Object],[object Object],[object Object]
When an IND is Required ,[object Object],[object Object],[object Object],[object Object]
When an IND is Not Required ,[object Object],[object Object],[object Object]
Examples ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmaceutical-Specific Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Typical Development Timeline ,[object Object]
An IND Supports 3 Phases of Clinical Development ,[object Object],[object Object],[object Object]
Phase 1 ,[object Object],[object Object],[object Object],[object Object]
Phase 1 (continued) ,[object Object],[object Object],[object Object]
Phase 2 ,[object Object],[object Object],[object Object]
Phase 3 ,[object Object],[object Object],[object Object],[object Object],[object Object]
IND Regulations and Guidance ,[object Object],[object Object],[object Object],[object Object],[object Object]
IND Content ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Content (continued) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Individual IND Sections
Cover Sheet - Form 1571 ,[object Object],[object Object],[object Object],[object Object]
Cover Sheet - Form 1571 (Cont.) ,[object Object],[object Object],[object Object],[object Object]
IND Table of Contents ,[object Object],[object Object],[object Object]
Introductory Statement and General Investigational Plan (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Introductory Statement and General Investigational Plan (2) ,[object Object],[object Object]
Introductory Statement and General Investigational Plan (3) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Investigator’s Brochure ,[object Object],[object Object],[object Object]
Investigator’s Brochure ,[object Object],[object Object],[object Object]
Clinical Protocols ,[object Object],[object Object],[object Object],[object Object]
Clinical Protocols (continued) ,[object Object],[object Object],[object Object]
Clinical Protocols (Continued) ,[object Object],[object Object],[object Object]
Clinical Investigator Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Form FDA 1572 ,[object Object],[object Object],[object Object]
Chemistry, Manufacturing, and Control (CMC) ,[object Object],[object Object],[object Object]
CMC (Continued) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC (Continued) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC (Continued) ,[object Object],[object Object],[object Object]
CMC (Continued) ,[object Object],[object Object]
Nonclinical Information ,[object Object]
Nonclinical Information (continued) ,[object Object],[object Object],[object Object]
Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Toxicology (continued) ,[object Object],[object Object]
Previous Human Experience ,[object Object],[object Object],[object Object]
Additional Information ,[object Object],[object Object],[object Object],[object Object]
Additional Information ,[object Object],[object Object],[object Object]
Other Considerations ,[object Object],[object Object],[object Object],[object Object]
Other Considerations (Continued) ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Review of an IND ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Review of an IND (continued) ,[object Object],[object Object],[object Object],[object Object]
FDA Review of an IND (continued) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Hold ,[object Object],[object Object],[object Object]
IND Success ,[object Object]
Useful URLs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Thank you!

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INDs: When Required and Contents

  • 1. Louise Johnson, M.S. INVESTIGATIONAL NEW DRUG APPLICATION (IND) Requirements for Filing and Contents of Submission The Bio2Device Group May 18, 2010
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