Get Ind Application For Botanical Drug Products - Ictr Johnshopkins

This guide provides a thorough overview of how to complete the IND Application for Botanical Drug Products, focusing on nonmarketed botanical products or those with known safety concerns. Users will find step-by-step instructions tailored to ensure a smooth online submission process.

Follow the steps to efficiently fill out the application online.

1. Click the ‘Get Form’ button to obtain the required form and open it for editing.
2. Complete the cover letter using the sponsor-investigator's letterhead. Include the FDA address, the date, and a brief description of the botanical drug product, specifying whether it is unmarketed or has safety concerns.
3. On the title page, insert relevant details including the date of application, the name of the botanical drug product, and sponsor-investigator information.
4. Fill out Form FDA 1571, ensuring it is signed and dated, providing links to form instructions if necessary.
5. Complete Form FDA 3674, also ensuring it is signed and dated.
6. Prepare the table of contents, outlining each section of the application clearly, especially if submitting multiple volumes.
7. Draft an introductory statement that includes the name of the botanical drug product, a brief description, and any relevant pre-IND meeting references.
8. Develop the general investigational plan, covering rationale, indications to be studied, evaluated general approaches, and anticipated risks based on previous studies.
9. If applicable, insert the investigator's brochure. If not, request a waiver from this requirement.
10. Complete the protocol section by detailing the clinical protocols that will be followed.
11. Detail the chemistry, manufacturing, and controls relevant to the botanical product, including all descriptions as specified by the FDA guidelines.
12. Compile any pharmacology and toxicology data necessary for the safety assessment of the proposed studies.
13. Summarize previous human experience related to the investigational drug, outlining any relevant studies and findings.
14. Include additional information as required by the application specifications, addressing any known drug dependence or abuse potential.
15. Review the submitted documents for completeness, save changes, download or print the application, and ensure all forms are correctly filled out and attached.

To begin your application process, click the ‘Get Form’ button and start filling out your IND Application for Botanical Drug Products online.