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nda-drug-application

100 / 100 · Low risk

Fine to try.

By lev-os/agents (GitHub) · writing · 28 stars · scanned at commit b247a6d

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.

Works with any agent that supports SKILL.md skills.

What this skill can do

We found nothing in the files we read that matches our rules. That does not prove the skill is safe: see the limits of static scanning.

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'nda-drug-application' ] || [ -L ~/.agents/skills/'nda-drug-application' ]; then echo 'A skill folder named nda-drug-application already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/lev-os/agents' "$d" && git -C "$d" checkout --quiet 'b247a6df3094b3f2c2780c0f34a9f05925627ffc' -- 'skills-db/legal/nda-drug-application' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills-db/legal/nda-drug-application' ~/.agents/skills/'nda-drug-application' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'nda-drug-application' ~/.claude/skills/'nda-drug-application' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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