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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

89%

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SecuritybySnyk

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SKILL.md
Quality
Evals
Security

Quality

Content

82%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.

Highly actionable reference documentation: every tool has concrete params, return shapes, gotchas, and executable examples, organized into a clear phased workflow with worked examples and a mistakes checklist. The main costs are token spend on regulatory background Claude already knows and duplication between the overview diagram and per-phase sections, plus the absence of error-recovery guidance for failed or empty tool calls.

Suggestions

Trim the Reasoning Framework section: drop facts Claude already knows (505(b)(2) definition, NCE=5yr/ODE=7yr/PED=6mo durations, TE-code meanings) and keep only the non-obvious interpretation rules, e.g., exclusivity can block generics after patent expiry and Purple Book vs Orange Book scope.

Remove duplication between the Workflow Overview diagram, the Supplementary tools block, and the per-phase sections — the diagram should show only phase names and outcomes, with the tool names appearing once in their phase sections.

Add brief error-recovery guidance for failed or empty tool calls (e.g., if FDAGSRS_search_substances returns no data, retry with a brand name or synonym from RxNorm_get_drug_names), completing the feedback loop the workflow otherwise lacks.

DimensionReasoningScore

Conciseness

Tool parameters, return shapes, and API gotchas (e.g., rela_source="DAILYMED" for EPC class IDs, UPPERCASE brand names, total_count may be None) are non-obvious and earn their tokens. However, the Reasoning Framework re-explains standard regulatory knowledge Claude already knows (505(b)(2) definition, NCE=5yr/ODE=7yr/PED=6mo durations), and the Workflow Overview diagram plus the Supplementary tools block duplicate the per-phase tool listings. Efficient with minor over-explanation fits anchor 4.

4 / 5

Actionability

Every tool entry has concrete parameters with types and defaults, return-shape descriptions, and usage guidance, plus executable Python snippets covering the common cases (substance lookup, class members, generic availability, adverse reactions, trial search). Copy-paste ready and specific, matching anchor 5.

5 / 5

Workflow Clarity

Eight clearly sequenced phases with a diagram, three worked example workflows, and a Common Mistakes checklist; explicit checkpoints exist ("always check FDA_OrangeBook_get_exclusivity before concluding a generic can enter", "check len(studies) > 0"). No error-recovery/feedback guidance for failed or empty tool calls (e.g., fallback when search returns no substances), which keeps it at anchor 4 rather than anchor 5. The destructive/batch validation cap does not apply — all operations are read-only API queries.

4 / 5

Progressive Disclosure

No bundle files (references/, scripts/, assets/) exist, so a self-contained SKILL.md is appropriate; sections are well-organized with headers, an overview diagram, and per-phase breakdowns that are easy to navigate. The ~280 lines of per-tool API detail could arguably be split into reference files, a minor organization gap that fits anchor 4.

4 / 5

Total

17

/

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 description: concrete, comprehensive capability list with an explicit Use-for clause covering multiple trigger scenarios and a jurisdiction-awareness rule. Only gap is a handful of natural user phrasings (patent expiration, drug label, adverse reactions) that appear in the body but not the description.

DimensionReasoningScore

Specificity

The description lists multiple concrete capabilities with named systems: "FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways". Coverage spans the whole regulatory workflow with no notable gaps, matching the comprehensive anchor rather than the 'minor gaps' anchor.

5 / 5

Completeness

It clearly answers what ("Drug regulatory and approval research — FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways") and when ("Use for jurisdiction-aware approval status (FDA vs EMA), generic vs brand availability, exclusivity expiry tracking, and regulatory pathway selection"), matching the anchor requiring both with concrete trigger phrases.

5 / 5

Trigger Term Quality

Natural keywords are present ("FDA", "generic-drug", "Orange Book", "exclusivity", "approval status", "NDA/BLA"), but common user phrasings like "patent expiration", "drug label", and "adverse reactions" — which the body's When to Use section covers — are absent from the description. Good coverage with a few natural terms missing fits anchor 4, not the comprehensive synonym coverage of anchor 5.

4 / 5

Distinctiveness Conflict Risk

A clear regulatory niche with distinct triggers (Orange Book, NDA/BLA, exclusivity, generic-drug status) that sibling drug skills (interactions, pharmacogenomics, mechanism) would not claim. Sibling-skill overlap is further reduced by the body's explicit NOT-for section, fitting the minimal-conflict anchor.

5 / 5

Total

19

/

20

Passed

Validation

93%

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

CriteriaDescriptionResult

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

Reviewed

Table of Contents

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