Cover letter/ Introduction (STATE CONTENTS)

- Submission Identifier - Brief explanation of the intended investigation - Investigational new drug product’s name and drug substance (AI) - P’cological class, structural formula - Proposed formulation (dosage form), route of administration, objectives bad duration of clinical investigation - Disease or condition under investigation - IND manufacturer’s name and contact information (if applicable) - Reference to an existing IND application (if applicable) Summary: Brief explanation, name of drug/chemical, formula, formulation, condition tx, manufacturer's info, reference