Getting it into your agent
One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.
npx skills add AndyZhuang/Opentest --skill regulatory-submissiongit clone --depth 1 https://github.com/AndyZhuang/OpentestWrote this? Show the measurements
A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.
[](https://agentmods.dev/skills/andyzhuang/opentest/regulatory-submission)<a href="https://agentmods.dev/skills/andyzhuang/opentest/regulatory-submission"><img src="https://agentmods.dev/badge/skills/andyzhuang/opentest/regulatory-submission/github.svg" alt="Measured on agentmods" height="20"></a>Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.
<a href="https://agentmods.dev/skills/andyzhuang/opentest/regulatory-submission"><img src="https://agentmods.dev/badge/skills/andyzhuang/opentest/regulatory-submission.svg" alt="Reviewed on agentmods" width="80" height="20"></a>What it costs to keep this loaded
Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.
| Model | Per session | Once invoked |
|---|---|---|
| Fable 5.1 | $0.00000 | $0.00406 |
| Opus 5 | $0.00000 | $0.00203 |
| Sonnet 5 | $0.00000 | $0.00081 |
| Haiku 4.5 | $0.00000 | $0.00041 |
Grade A, and why
regulatory-submission scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 8d ago.
A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.
Nothing flagged
None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.
This is a copy
100% identical to regulatory-submission — 0 lines differ, which has more behind it and is treated as the original. This page carries a canonical link to it rather than competing with it.
What it actually says
Regulatory Submission — FDA/EMA Dossier Structure
Overview
Prepare regulatory submissions for drugs, biologics, devices, and diagnostics.
Common Submission Types
FDA (United States)
| Type | Purpose | Key Sections |
|---|---|---|
| IND | Investigational New Drug | Chemistry, pharmacology, toxicology, clinical protocol |
| NDA | New Drug Application | Full CMC, nonclinical, clinical data |
| BLA | Biologics License | Manufacturing, characterization, clinical |
| 510(k) | Device clearance | Substantial equivalence, performance testing |
| PMA | Device approval | Clinical data, manufacturing |
| EUA | Emergency use | Available data, benefit-risk |
EMA (European Union)
| Type | Purpose |
|---|---|
| CTA | Clinical Trial Application |
| MAA | Marketing Authorization Application |
| Scientific Advice | Pre-submission guidance |
CTD Format (Common Technical Document)
Module 1: Administrative
- Cover letters, application forms, labeling
Module 2: Summaries
- 2.1 CTD table of contents
- 2.2 CTD introduction
- 2.3 Quality overall summary
- 2.4 Nonclinical overview
- 2.5 Clinical overview
- 2.6 Nonclinical written summaries
- 2.7 Clinical summaries
Module 3: Quality (CMC)
- Drug substance, drug product, manufacturing, controls
Module 4: Nonclinical
- Pharmacology, pharmacokinetics, toxicology
Module 5: Clinical
- Clinical study reports, literature references
Key Principles
- Follow ICH guidelines (ICH E6 GCP, ICH Q1-Q12)
- Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)
- Risk-based approach: prioritize critical quality attributes
- Lifecycle management: post-approval changes and variations
What this file has done since we first saw it
Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.
- 8d ago First seen · 52 lines · 0 tokens per session scan A 8ed04a95ccab
regulatory-submission is a skill published in the GitHub repository AndyZhuang/Opentest (22 stars, last pushed 6mo ago), licensed MIT. It costs nothing until one of its globs matches a file; then it loads 406 tokens. A static security scan graded it A with 0 findings. It is 100% identical to regulatory-submission, differing in 0 lines, and is treated as a copy.
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