tooluniverse-drug-regulatory

Drug regulatory and approval research — FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways. Use for jurisdiction-aware approval status (FDA vs EMA), generic vs brand availability, exclusivity expiry tracking, and regulatory pathway selection. Always specifies the market when reporting status.

Quality

81%

Does it follow best practices?

Run evals on this skill

Adds up to 20 points to the overall score

View guide

Securityby

Passed

No findings from the security scan

Quality

Content

71%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

A highly actionable, well-sequenced skill body with executable examples across all phases. It is held back by an over-explanatory Interpretation Guidance section and by inlining the full API reference instead of offloading it to reference files.

Suggestions

Trim or remove the "Interpretation Guidance" subsection (505(b)(1)/(b)(2)/ANDA, NCE/ODE/PED/TE definitions) — these are concepts Claude already knows and consume context budget.

Move the per-tool parameter/return API reference into a references/ file (e.g. references/tools.md) and keep only a phase-by-phase overview plus key examples in SKILL.md, linking out for the bulk reference.

Add explicit validation checkpoints to the workflows (e.g. confirm a UNII was returned before calling FDAGSRS_get_substance; verify generic_availability response before reporting generic status) to strengthen feedback loops.

Dimension	Reasoning	Score
Conciseness	Mostly tool-reference dense and assumes competence, but the "Interpretation Guidance" and "Synthesis Questions" sections restate concepts Claude already knows (505(b)(1)/505(b)(2)/ANDA definitions, NCE/ODE/PED/TE code meanings) and could be trimmed.	3 / 5
Actionability	Fully executable, copy-paste-ready code blocks (e.g. `tu.tools.FDAGSRS_search_substances(query="semaglutide")`) with concrete typed params, return shapes, and three complete worked workflows covering common cases.	5 / 5
Workflow Clarity	A clear 8-phase sequenced overview with per-phase tool detail and some checkpoints (e.g. "check len(studies) > 0"), but explicit validate→fix→retry feedback loops are largely absent.	4 / 5
Progressive Disclosure	Well-sectioned by phase, but no bundle/reference files exist and the bulk per-tool API reference (params, returns) is inlined in SKILL.md rather than split into one-level-deep referenced files.	3 / 5
	Total	15 / 20 Passed

Description

92%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A strong, specific description that concretely names capabilities and gives explicit "Use for" triggers with multiple scenarios. The only soft spot is trigger-term quality, which leans slightly technical over natural user phrasing.

Dimension	Reasoning	Score
Specificity	Lists multiple specific concrete actions — "FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways" — with comprehensive domain coverage.	5 / 5
Completeness	Clearly answers both what ("Drug regulatory and approval research — ...") and when ("Use for jurisdiction-aware approval status (FDA vs EMA), generic vs brand availability, exclusivity expiry tracking, and regulatory pathway selection") with concrete trigger phrases.	5 / 5
Trigger Term Quality	Good keyword coverage with synonyms (FDA/EMA, generic/brand, NDA/BLA) and natural phrases like "generic vs brand availability" and "exclusivity expiry tracking", but slightly jargon-heavy and missing a few lay terms a user might say.	4 / 5
Distinctiveness Conflict Risk	A sharply defined drug-regulatory niche with distinct triggers and an explicit differentiator ("Always specifies the market when reporting status") that minimizes overlap with adjacent skills.	5 / 5
	Total	19 / 20 Passed

Validation

93%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 15 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning

	Total	15 / 16 Passed

Repository: mims-harvard/ToolUniverse
Path: plugin/skills/tooluniverse-drug-regulatory/SKILL.md
Commit: 1b02920

Reviewed: 1 day ago

Table of Contents

Discovery Implementation Validation

Is this your skill?

If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.