nda-drug-application

name	nda-drug-application
title	New Drug Application (NDA)
description	Drafts an eCTD-compliant New Drug Application (NDA) for FDA submission under 21 CFR Part 314. Compiles clinical trial data, CMC documentation, nonclinical studies, pharmacokinetics, integrated safety analyses, and proposed labeling into five-module eCTD structure. Use when preparing an NDA, FDA drug approval submission, pharmaceutical regulatory filing, or eCTD assembly for a new molecular entity.
author	CaseMark
author_url	https://github.com/CaseMark/skills/tree/main/skills/legal/nda-drug-application
license	Apache-2.0
version	0.1.0
execution_mode	open
jurisdiction	us
practice	life-sciences
language	en
tags	["analysis","drafting"]

New Drug Application (NDA)

Drafts an eCTD-compliant NDA demonstrating safety and efficacy for FDA submission under 21 CFR Part 314.

Prerequisites

1. Clinical trial data — Phase 1–3 protocols, CSRs, statistical analyses, patient demographics
2. CMC documentation — drug substance characterization, manufacturing process, batch records, stability data
3. Nonclinical study reports — pharmacology, toxicology (general, genetic, reproductive, carcinogenicity), safety pharmacology
4. PK/bioavailability data — human PK, special populations, DDI studies, exposure-response analyses
5. Regulatory correspondence — pre-IND/pre-NDA meeting minutes, special protocol assessments, FDA feedback
6. Proposed labeling drafts — if available
7. Patent and exclusivity information — patent numbers, expiration dates, exclusivity claims

Output Structure

Module 1: Administrative Information

Element	Requirements
Cover letter	Sponsor details, application type, regulatory pathway, special designations (breakthrough, fast track, priority review, orphan)
FDA Form 356h	User fee info, debarment certification, field copy designations
Proposed names	Proprietary and established names
Indication statement	Precise medical terminology, dosage form, route, strength(s)
Regulatory strategy	Reference pre-submission meetings, SPAs, unmet medical need narrative

Module 2: Summaries

2.5 Integrated Summary & Benefit-Risk

• Pharmacological class, MOA, therapeutic rationale
• Development program overview (nonclinical → Phase 1 → 2 → 3 logic)
• Pivotal trial summaries: design, population, endpoints, results (point estimates, CIs, p-values)
• Integrated safety: AE profile across program, SAEs, deaths, safety signals
• Risk mitigation: labeling, REMS if applicable
• Benefit-risk weighing per 21 CFR 314.50(c): efficacy magnitude vs. AE frequency/severity, disease seriousness, existing therapies

2.3 Quality Overall Summary (CMC)

Area	Key Elements
Drug substance