Module 1administrativendaind

1.2 — Cover Letter

Cover letter identifying the IND submission type, serial number, and key information

Requirements by Phase

Phase 1

required

Phase 2

required

Phase 3

required

NDA

required

Cover letter identifying the IND submission type, serial number, and key information

Requirements by Phase

IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required

Content Requirements

Identification of submission type (original, amendment, supplement)
Serial number of submission
Drug name (proprietary and non-proprietary)
IND number (if assigned)
Brief description of submission contents
Contact information for regulatory correspondence

Expected Deliverables

Cover letter (PDF)

ICH Guidelines: 21 CFR 312.23(a)(1)

Source: 21 CFR 312.23(a)(1)

References

21 CFR 312.23(a)(1)

Sections

1.2.1 — Application Form (FDA Form 356h)

FDA Form 356h application form for NDA/BLA submissions

1.2.2 — Form FDA 1571 (IND)

FDA Form 1571 IND application cover form

1.2.3 — Form FDA 1572 (Statement of Investigator)

FDA Form 1572 signed statement from each participating investigator

1.2.4 — Form FDA 3674 (ClinicalTrials.gov)

FDA Form 3674 certification of compliance with ClinicalTrials.gov requirements

1.2.5 — Prescribing Information / Labeling

Prescribing information and approved labeling for NDA

1.2.6 — Patent Information

Patent information for Orange Book listing

1.2.7 — Exclusivity Claims

Exclusivity claims (orphan, pediatric, NCE)

Related Sections

Up toModule 1: Administrative Information and Prescribing Information

1.1 — Table of Contents

Complete table of contents for the submission

1.3 — Administrative Information

Administrative information including contact details, certifications, and financial disclosures

1.4 — References

Letters of authorization, right of reference statements, and cross-references to other applications

1.5 — Application Status

Application status requests including withdrawal, inactivation, and reactivation

1.6 — Meetings

Meeting requests and minutes for pre-IND, pre-NDA/BLA, and Type A/B/C meetings

+6 more sections

Check your compliance against this section

Upload your study data and get instant gap analysis with specific regulatory citations.

Try Compliance Check