INDs: When Required and Contents

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],[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]

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]

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]

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!

INDs: When Required and Contents

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