ind-application

name	ind-application
title	IND Application
description	Drafts FDA Investigational New Drug (IND) applications under 21 CFR Part 312, including Form 1571, Investigator's Brochure, clinical protocols, CMC sections, and nonclinical data packages. Use when preparing IND submissions, pre-IND packages, IND amendments, or clinical trial authorization documents.
author	CaseMark
author_url	https://github.com/CaseMark/skills/tree/main/skills/legal/ind-application
license	Apache-2.0
version	0.1.0
execution_mode	open
jurisdiction	us
practice	life-sciences
language	en
tags	["drafting","memo"]

IND Application

Drafts a complete IND application under 21 CFR Part 312 for FDA authorization to begin human clinical trials.

Prerequisites

Collect before drafting:

1. Drug substance/product info — chemical name, code designation, structural formula, mechanism of action
2. Nonclinical reports — pharmacology, toxicology, PK/PD data
3. CMC data — manufacturing process, specifications, stability, certificates of analysis
4. Clinical protocol(s) — design, objectives, endpoints, statistical analysis plan
5. Investigator info — CVs, Form FDA 1572, clinical site details
6. Prior human experience (if any) — foreign trials, literature, compassionate use
7. IRB documentation — approval letters or submission plans, informed consent forms

Quick Start

1. Confirm trial phase (I/II/III) — this drives CMC depth and nonclinical requirements
2. Complete Form 1571 cover sheet
3. Draft sections in 21 CFR 312.23(a) order (see below)
4. Cross-reference all nonclinical citations to specific IND sections
5. Run checklists for Form 1571, IB, protocol, and environmental assessment

IND Section Order (21 CFR 312.23(a))

#	Section	Reference
1	Cover Sheet — FDA Form 1571	312.23(a)(1)
2	Table of Contents — mirror regulatory numbering	312.23(a)(2)
3	Introductory Statement — rationale, therapeutic purpose, investigational plan	312.23(a)(3)
4	Investigator's Brochure — safety, efficacy, pharmacology, known risks	312.23(a)(5)
5	Clinical Protocol(s) — design, dosing, safety monitoring, statistical plan	312.23(a)(6)
6	CMC: Drug Substance — synthesis, specs, stability	312.23(a)(7)
7	CMC: Drug Product — formulation, controls, container/closure, stability	312.23(a)(7)
8	Pharmacology/Toxicology — PK, acute/chronic tox, repro tox, genotox	312.23(a)(8)
9	Previous Human Experience — prior clinical data, foreign trials, literature