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1. Pre-IND Meeting Preparation Request a Pre-IND Meeting: Schedule a meeting with the FDA to discuss your IND submission.

Prepare Meeting Package: Include proposed clinical trial design, preclinical data, manufacturing information, and any other relevant data.

Submit Questions: Prepare a list of specific questions for the FDA regarding your IND submission.

2. Form FDA 1571 Complete Form FDA 1571: Ensure all sections are filled out accurately, including sponsor information, drug information, and clinical trial details.

Signature: Obtain the required signature from the sponsor or authorized representative.

3. Table of Contents Create a Comprehensive Table of Contents: Organize the IND submission with clear sections and page numbers for easy navigation.

4. Introductory Statement and General Investigational Plan Introductory Statement: Provide a brief overview of the drug, including its name, structure, and pharmacological class.

General Investigational Plan: Outline the clinical development plan, including the objectives and duration of the proposed studies.

5. Investigator's Brochure Compile the Investigator's Brochure: Include all relevant information about the drug, such as its formulation, pharmacology, toxicology, and clinical data.

Update as Necessary: Ensure the brochure is up-to-date with the latest data.

6. Clinical Protocol Develop Clinical Protocol: Detail the study design, including objectives, patient population, dosing regimen, and endpoints.

Inclusion/Exclusion Criteria: Clearly define the criteria for patient selection.

Safety Monitoring: Outline the procedures for monitoring patient safety.

7. Chemistry, Manufacturing, and Control (CMC) Information Drug Substance Information: Provide details on the drug substance, including its manufacture, characterization, and controls.

Drug Product Information: Include information on the drug product, such as formulation, manufacturing process, and specifications.

Stability Data: Submit stability data to support the proposed shelf life of the drug.

Labeling: Provide draft labeling for the investigational drug.

8. Pharmacology and Toxicology Data Pharmacology Studies: Submit data from in vitro and in vivo studies that demonstrate the drug's pharmacological effects.

Toxicology Studies: Include data from acute, subacute, and chronic toxicity studies, as well as reproductive and genotoxicity studies.

Safety Pharmacology: Provide data on the drug's effects on vital organ systems.

9. Previous Human Experience Summarize Previous Human Experience: If applicable, include data from previous clinical trials or use in humans.

Safety and Efficacy Data: Highlight any relevant safety and efficacy findings from prior studies.

10. Additional Information Environmental Assessment: Submit an environmental assessment or claim an exclusion if applicable.

Special Considerations: Include any additional information that may be relevant, such as data from pediatric studies or risk management plans.

11. Review and Quality Control Internal Review: Conduct a thorough internal review of the IND submission to ensure accuracy and completeness.

Quality Control: Verify that all data and documents meet regulatory standards and guidelines.

12. Submission to FDA Compile the IND Submission: Assemble all sections into a single, well-organized submission.

Submit to FDA: Send the IND submission to the appropriate FDA division via the required submission method (e.g., electronic submission).

Confirmation of Receipt: Obtain confirmation from the FDA that the IND has been received and is under review.