General/Formatting Information: Delete all instructional text Format page numbers to match the Table of Contents based on your specific IND application, the numbers indicated on the TOC are not uniform and are included to help format. If sections are not applicable to your study, state Applicable” under the main section. “Not Ex: ADDITIONAL INFORMATION” is Applicable’. “10. “Not In the headings, the FDA of Federal Regulations Title 21” is hyperlinked into the specific section “Code of the IND Application that the section covers. Use this if extra information is wanted regarding the details about that section of the application. Ex: This indicator refers to the of Regulations Title 21” and specifically the 10th piece under “Code section 312.23 (a), Information”. “Additional Also, some definitions are linked, such as substance” and product for sections that are “drug “drug” applicable as they are commonly mixed-up. [21 CFR 210.3(b)(9)] Ex: This indicator refers to the of Regulations Title 21” and specifically the 9th piece under section b “Code of 210.3(b) (definitions) and describes an ingredient”. “active
General/Formatting Information: Delete all instructional text Format page numbers to match the Table of Contents based on your specific IND application, the numbers indicated on the TOC are not uniform and are included to help format. If sections are not applicable to your study, state “Not Applicable” under the main section. Ex: “10. ADDITIONAL INFORMATION” is “Not Applicable’. In the headings, the FDA “Code of Federal Regulations Title 21” is hyperlinked into the specific section of the IND Application that the section covers. Use this if extra information is wanted regarding the details about that section of the application. Ex: This indicator refers to the “Code of Regulations Title 21” and specifically the 10th piece under section 312.23 (a), “Additional Information”. Also, some definitions are linked, such as “drug substance” and “drug” product for sections that are applicable as they are commonly mixed-up. Ex: [21 CFR 210.3(b)(9)] This indicator refers to the “Code of Regulations Title 21” and specifically the 9th piece under section b of 210.3(b) (definitions) and describes an “active ingredient”.
Indiana-CTSI-Initial-IND-Application.docx