eCTD Guide Explorer
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Explore regional Module 1 documents and the common CTD structure for Modules 2–5. Start with our FDA catalog and draft writing guides.
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Current coverage: FDA Module 1 and FDA catalog headings for Modules 2–5.
Draft library308 sections
1.1Forms7 guides
FDA eCTD v4.0 placement: 1.1. Applicability depends on the application, submission purpose and product.
How to prepare FDA Form 356hWhich FDA form belongs with your submission?How to prepare Form FDA 1571 for an IND submissionHow to prepare and review Form FDA 1572How to prepare Form FDA 3674 without guessing the certificationHow to prepare Form FDA 2253 for promotional materialsHow to prepare Form FDA 3926 for individual patient expanded accessOpen the official FDA hierarchy ↗1.2Cover letters1 guide
FDA eCTD v4.0 placement: 1.2. Applicability depends on the application, submission purpose and product.
How to write an FDA submission cover letter and reviewer guideOpen the official FDA hierarchy ↗1.3Administrative information1 guide
FDA eCTD v4.0 placement: 1.3. Applicability depends on the application, submission purpose and product.
Plan Module 1 administrative information around the actual changeOpen the official FDA hierarchy ↗1.3.1Contact/sponsor/applicant information1 guide
FDA eCTD v4.0 placement: 1.3.1. Applicability depends on the application, submission purpose and product.
Plan Module 1 administrative information around the actual changeOpen the official FDA hierarchy ↗1.3.1.1Change of address or corporate name1 guide
FDA eCTD v4.0 placement: 1.3.1.1. Applicability depends on the application, submission purpose and product.
How to document a name, address, contact or agent changeOpen the official FDA hierarchy ↗1.3.1.2Change in contact/agent1 guide
FDA eCTD v4.0 placement: 1.3.1.2. Applicability depends on the application, submission purpose and product.
How to document a name, address, contact or agent changeOpen the official FDA hierarchy ↗1.3.1.3Change in sponsor1 guide
FDA eCTD v4.0 placement: 1.3.1.3. Applicability depends on the application, submission purpose and product.
How to prepare an IND sponsor-change handoffOpen the official FDA hierarchy ↗1.3.1.4Transfer of obligation1 guide
FDA eCTD v4.0 placement: 1.3.1.4. Applicability depends on the application, submission purpose and product.
How to document an IND transfer of obligations to a CROOpen the official FDA hierarchy ↗1.3.1.5Change in ownership of an application or reissuance of license1 guide
FDA eCTD v4.0 placement: 1.3.1.5. Applicability depends on the application, submission purpose and product.
Prepare an application ownership transfer or biologic license reissuanceOpen the official FDA hierarchy ↗1.3.2Field copy certification1 guide
FDA eCTD v4.0 placement: 1.3.2. Applicability depends on the application, submission purpose and product.
How to prepare an eCTD field-copy certification letterOpen the official FDA hierarchy ↗1.3.3Debarment certification1 guide
FDA eCTD v4.0 placement: 1.3.3. Applicability depends on the application, submission purpose and product.
How to prepare a debarment certificationOpen the official FDA hierarchy ↗1.3.4Financial certification and disclosure1 guide
FDA eCTD v4.0 placement: 1.3.4. Applicability depends on the application, submission purpose and product.
How to prepare Forms FDA 3454 and 3455 financial disclosuresOpen the official FDA hierarchy ↗1.3.5Patent and exclusivity1 guide
FDA eCTD v4.0 placement: 1.3.5. Applicability depends on the application, submission purpose and product.
Patent information, patent certification and exclusivity: choose the right taskOpen the official FDA hierarchy ↗1.3.5.1Patent information1 guide
FDA eCTD v4.0 placement: 1.3.5.1. Applicability depends on the application, submission purpose and product.
How to prepare Forms FDA 3542a and 3542 patent informationOpen the official FDA hierarchy ↗1.3.5.2Patent certification1 guide
FDA eCTD v4.0 placement: 1.3.5.2. Applicability depends on the application, submission purpose and product.
How to prepare an ANDA or 505(b)(2) patent-certification packageOpen the official FDA hierarchy ↗1.3.5.3Exclusivity claim1 guide
FDA eCTD v4.0 placement: 1.3.5.3. Applicability depends on the application, submission purpose and product.
How to write an NDA exclusivity claim with supporting evidenceOpen the official FDA hierarchy ↗1.3.6Tropical disease priority review voucher1 guide
FDA eCTD v4.0 placement: 1.3.6. Applicability depends on the application, submission purpose and product.
Prepare a tropical-disease priority review voucher requestOpen the official FDA hierarchy ↗1.4References1 guide
FDA eCTD v4.0 placement: 1.4. Applicability depends on the application, submission purpose and product.
Prepare rights of reference and cross-references to prior FDA submissionsOpen the official FDA hierarchy ↗1.4.1Letter of authorization1 guide
FDA eCTD v4.0 placement: 1.4.1. Applicability depends on the application, submission purpose and product.
How to prepare a DMF letter of authorizationOpen the official FDA hierarchy ↗1.4.2Statement of right of reference1 guide
FDA eCTD v4.0 placement: 1.4.2. Applicability depends on the application, submission purpose and product.
Prepare rights of reference and cross-references to prior FDA submissionsOpen the official FDA hierarchy ↗1.4.3List of authorized persons to incorporate by reference1 guide
FDA eCTD v4.0 placement: 1.4.3. Applicability depends on the application, submission purpose and product.
Prepare rights of reference and cross-references to prior FDA submissionsOpen the official FDA hierarchy ↗1.4.4Cross-reference to previously submitted information1 guide
FDA eCTD v4.0 placement: 1.4.4. Applicability depends on the application, submission purpose and product.
Prepare rights of reference and cross-references to prior FDA submissionsOpen the official FDA hierarchy ↗1.5Application status1 guide
FDA eCTD v4.0 placement: 1.5. Applicability depends on the application, submission purpose and product.
Choose the correct FDA application status-change documentOpen the official FDA hierarchy ↗1.5.1Withdrawal of an IND1 guide
FDA eCTD v4.0 placement: 1.5.1. Applicability depends on the application, submission purpose and product.
How to prepare an IND withdrawal letter and closeout recordOpen the official FDA hierarchy ↗1.5.2Inactivation request1 guide
FDA eCTD v4.0 placement: 1.5.2. Applicability depends on the application, submission purpose and product.
How to prepare IND inactivation and reactivation requestsOpen the official FDA hierarchy ↗Section placement shows where information belongs, not whether it is required for your application.
Catalog: FDA comprehensive hierarchy, version 2.2, February 2025. Source checked September 22, 2026. Writing guides by Assyro.