ind-application

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.

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仓库: ThomasMoreAI/legal-skills-open
最近来源活动: 2026年6月11日 14:38
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SKILL.md

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fetching-arbitration-rules

Use when retrieving arbitration institutional rules (ICC, LCIA, SCC, SIAC, HKIAC, VIAC, МКАС/МАК при ТПП України, UNCITRAL) — fetching current version, verifying redaction applicable to the date of arbitration agreement, constructing URLs for official rule texts

2026-06-12

determining-pl-request-regime

Use when choosing the Polish legal regime for letters, requests, applications, complaints, petitions, public-information requests, KPA filings, PPSA complaints, RODO access requests, registry extracts, court-file access, tax/ZUS/cudzoziemcy/USC procedures, or professional lawyer letters. Prevents mixing UDIP, KPA, PPSA, RODO, registry, special-procedure, and advocate/radca letter regimes.

2026-06-12

applying-new-york-convention

Use when preparing applications for recognition and enforcement of foreign arbitral awards in Poland, applications for setting aside arbitral awards under KPC art. 1205–1211, or opposing such applications — mapping Article V of the 1958 New York Convention to art. 1214–1215 of the Polish KPC, identifying grounds for refusal, structuring public policy arguments

2026-06-12

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IND Application

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

Prerequisites

Collect before drafting:

Drug substance/product info — chemical name, code designation, structural formula, mechanism of action

Nonclinical reports — pharmacology, toxicology, PK/PD data

CMC data — manufacturing process, specifications, stability, certificates of analysis

Clinical protocol(s) — design, objectives, endpoints, statistical analysis plan

Investigator info — CVs, Form FDA 1572, clinical site details

Prior human experience (if any) — foreign trials, literature, compassionate use

IRB documentation — approval letters or submission plans, informed consent forms

Quick Start

Confirm trial phase (I/II/III) — this drives CMC depth and nonclinical requirements

Complete Form 1571 cover sheet

Draft sections in 21 CFR 312.23(a) order (see below)

Cross-reference all nonclinical citations to specific IND sections

Run checklists for Form 1571, IB, protocol, and environmental assessment

IND Section Order (21 CFR 312.23(a))

Section

Reference

Cover Sheet — FDA Form 1571

312.23(a)(1)

Table of Contents — mirror regulatory numbering

312.23(a)(2)

Introductory Statement — rationale, therapeutic purpose, investigational plan

312.23(a)(3)

Investigator's Brochure — safety, efficacy, pharmacology, known risks

312.23(a)(5)

Clinical Protocol(s) — design, dosing, safety monitoring, statistical plan

312.23(a)(6)

CMC: Drug Substance — synthesis, specs, stability

312.23(a)(7)

CMC: Drug Product — formulation, controls, container/closure, stability

312.23(a)(7)

Pharmacology/Toxicology — PK, acute/chronic tox, repro tox, genotox

312.23(a)(8)

Previous Human Experience — prior clinical data, foreign trials, literature

IND Application

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

Prerequisites

Collect before drafting:

Drug substance/product info — chemical name, code designation, structural formula, mechanism of action

Nonclinical reports — pharmacology, toxicology, PK/PD data

CMC data — manufacturing process, specifications, stability, certificates of analysis

Clinical protocol(s) — design, objectives, endpoints, statistical analysis plan

Investigator info — CVs, Form FDA 1572, clinical site details

Prior human experience (if any) — foreign trials, literature, compassionate use

IRB documentation — approval letters or submission plans, informed consent forms

Quick Start

Confirm trial phase (I/II/III) — this drives CMC depth and nonclinical requirements

Complete Form 1571 cover sheet

Draft sections in 21 CFR 312.23(a) order (see below)

Cross-reference all nonclinical citations to specific IND sections

Run checklists for Form 1571, IB, protocol, and environmental assessment

IND Section Order (21 CFR 312.23(a))

Section

Reference

Cover Sheet — FDA Form 1571

312.23(a)(1)

Table of Contents — mirror regulatory numbering

312.23(a)(2)

Introductory Statement — rationale, therapeutic purpose, investigational plan

312.23(a)(3)

Investigator's Brochure — safety, efficacy, pharmacology, known risks

312.23(a)(5)

Clinical Protocol(s) — design, dosing, safety monitoring, statistical plan

312.23(a)(6)

CMC: Drug Substance — synthesis, specs, stability

312.23(a)(7)

CMC: Drug Product — formulation, controls, container/closure, stability

312.23(a)(7)

Pharmacology/Toxicology — PK, acute/chronic tox, repro tox, genotox

312.23(a)(8)

Previous Human Experience — prior clinical data, foreign trials, literature

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"]

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"]

Phase	Drug Substance	Drug Product	Stability
I	Synthetic route, preliminary specs, structure confirmation	Formulation description, basic controls	Abbreviated (cover trial duration)
II	Refined process, tightened specs, impurity profiles	Validation initiated, expanded controls	6+ months accelerated + long-term
III	Full process validation, complete characterization	Full cGMP, container/closure validation	ICH-compliant program

ind-application

安装方式

检查来源文件

IND Application

Prerequisites

Quick Start

IND Section Order (21 CFR 312.23(a))

IND Application

Prerequisites

Quick Start

IND Section Order (21 CFR 312.23(a))

Key Checklists

Form 1571

Investigator's Brochure

Clinical Protocol

Phase-Appropriate CMC Depth

Nonclinical Study Table Format

Environmental Assessment

Pitfalls and Checks

ind-application

来源信息

安装方式

检查来源文件

同仓库更多 Skills

同仓库更多 Skills

IND Application

Prerequisites

Quick Start

IND Section Order (21 CFR 312.23(a))

IND Application

Prerequisites

Quick Start

IND Section Order (21 CFR 312.23(a))

Key Checklists

Form 1571

Investigator's Brochure

Clinical Protocol

Phase-Appropriate CMC Depth

Nonclinical Study Table Format

Environmental Assessment

Pitfalls and Checks