fda-catalyst-medicines

fda-catalyst-medicines is a skill for Claude Code from agentii-ai/agentii-investment-intelligence. It costs 77 tokens per session (2,030 once invoked), scanned A, original, Apache-2.0.

A research tool for tracking US regulatory and market events for medicines, including FDA decision dates, advisory votes, label expansions, biosimilars, patents, and rejection follow-up.

In plain words
What is it for?
Use it to monitor PDUFA dates, advisory committee meetings, label changes, biosimilar rights, Orange Book status, and plans after a complete response letter.
Why use it?
Drug investment timelines depend on several regulatory and exclusivity events, not just a single approval date.

Skill for Claude Code

Written for Claude Code: allowed-tools in frontmatter.

Part of the bio-pharm plugin — 15 skills shipped together

Good fit Use it to monitor PDUFA dates, advisory committee meetings, label changes, biosimilar rights, Orange Book status, and plans after a complete response letter.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines
Install

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.

Any agent
npx skills add agentii-ai/agentii-investment-intelligence --skill fda-catalyst-medicines
Clone the repo
git clone --depth 1 https://github.com/agentii-ai/agentii-investment-intelligence

Made for: Claude Code.

Or install bio-pharm, the plugin that ships this one along with the rest of its 15 skills.

Wrote 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.

agentmods badge for fda-catalyst-medicines

README.md
[![agentmods](https://agentmods.dev/badge/skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines/github.svg)](https://agentmods.dev/skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines)
Your own site
<a href="https://agentmods.dev/skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines"><img src="https://agentmods.dev/badge/skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines/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.

agentmods 80×15 button for fda-catalyst-medicines

Your own site · 80×15
<a href="https://agentmods.dev/skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines"><img src="https://agentmods.dev/badge/skills/agentii-ai/agentii-investment-intelligence/fda-catalyst-medicines.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 77 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 2,030 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin original No closer match found in the catalogue.
Token cost

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.

ModelPer sessionOnce invoked
Fable 5.1 $0.00077 $0.02030
Opus 5.5 $0.00031 $0.00812
Sonnet 5.5 $0.00015 $0.00406
Haiku 4.5 $0.00008 $0.00203

Measured 1mo ago against content hash d456a7272a86, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

fda-catalyst-medicines 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 1mo 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.

marketplace-beachhead/plugins/bio-pharm/skills/agentii/fda-catalyst-medicines/SKILL.md · 167 lines

How it starts

The opening of the file, as written. The whole thing — 167 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Methodology inspired by publicly taught biotech catalyst frameworks; all text is an original paraphrase.

Defaults

Parameter Default Value Rationale
forward_window_quarters 4 Standard catalyst window; extend to 8 on request
include_superseded false Active-only events by default; supersede chains on request
exclusivity_tracking true Orange Book and 180-day exclusivity state attached to launch-relevant events
holiday_labeling true Holiday-shifted weeks flagged on every calendar row
horizon_days 180 Default for get_upcoming_pdufa horizon

Preflight

Run canonical pre-flight per contracts/preflight.md. Include the X-Agentii-Trace header on every tool call per contracts/x-agentii-trace-header.md — carry the _run_id from your first tool result and name yourself (and your parent, if you were spawned). Confirm ticker resolution via search_companies before catalyst queries.

Triggers

  • "When is the PDUFA date for [drug/ticker]?"
  • "What AdCom meetings are coming up for [ticker]?"
  • "Has [drug]'s sNDA/sBLA label expansion been approved?"
  • "Which biosimilars have interchangeability designation, and when does 180-day exclusivity run?"
  • "What is [drug]'s Orange Book patent and exclusivity state?"
  • "How is [ticker]'s CRL remediation timeline shaping up?"
  • "Build a PDUFA/AdCom calendar for my pharma watchlist."
  • "Evaluate the approval odds for [drug] ahead of its AdCom."
  • "What label expansions are pending for [ticker] this year?"
  • "Which medicine decisions land this quarter?"
  • "How do biosimilar launches erode the reference product's share?"
  • "Which catalysts overlap with [ticker]'s earnings date?"

Production Grounding

  • CDER mechanics: NDA/BLA review tracks, PDUFA target dates, priority review, breakthrough designation, accelerated approval, CRL deficiency classes and the remediation reset, AdCom vote patterns.
  • Label expansions (sNDA/sBLA) are the commercial catalysts beyond first approval; Orange Book patent and exclusivity state sets the generic or biosimilar entry window.
  • Biosimilar timeline note: interchangeability plus 180-day exclusivity for the first interchangeable delays competing entry — and approval is not launch; commercial timing follows exclusivity expiry and patent-settlement terms.
  • Holiday-week labeling discipline: comps across holiday-shifted weeks are noisy; every calendar row carries its caveat, and holiday weeks are labeled explicitly.
  • Apply AdCom-style scrutiny axes when framing outcome odds; never fabricate dates, votes, or outcomes — annotate coverage gaps instead (per references/knowledge-frameworks.md).

Read the full file on GitHub · 167 lines

Files

What ships with it

2 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

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.

  1. 1mo ago Changed d456a7272a86
  2. 1mo ago First seen · 167 lines · 77 tokens per session scan A efdc962aa68e

Subscribe to this mod's changes

fda-catalyst-medicines is a skill published in the GitHub repository agentii-ai/agentii-investment-intelligence (208 stars, last pushed yesterday), licensed Apache-2.0. It adds 77 tokens to every session and 2,030 once invoked, about $0.0003 per session on Opus 5.5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-15.

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