CtrlK
BlogDocsLog inGet started
Tessl Logo
SkillPublic

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

78%

Does it follow best practices?

Run evals on this skill

Adds up to 20 points to the overall score

View guide
SecuritybySnyk

Passed

No findings from the security scan

Fix and improve this skill with Tessl

tessl review fix ./plugins/tooluniverse/skills/tooluniverse-drug-regulatory/SKILL.md

The canonical home for this skill is tooluniverse-drug-regulatory in mims-harvard/ToolUniverse

SKILL.md
Quality
Evals
Security

Quality

Content

63%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.

The body is a well-organized, highly actionable tool orchestration guide with a clear phase sequence, concrete parameter documentation, worked examples, and a valuable Common Mistakes section. Its main weaknesses are redundancy (exclusivity/FAERS details and basic pharmacology explained twice or unnecessarily) and the absence of progressive disclosure — all API reference lives inline in SKILL.md with no bundle files.

Suggestions

Move the per-tool parameter/return documentation for the eight phases into a references/ file (e.g., references/tools.md), keeping SKILL.md as a lean overview with the workflow diagram, key gotchas, and one example per phase.

Deduplicate the exclusivity-code explanations (Phase 4 vs. Reasoning Framework) and drop the basic pharmacology definitions (ANDA/505(b)(2), Cmax/AUC/half-life) that Claude already knows, keeping only the non-obvious regulatory facts (NCE=5yr, ODE=7yr, PED=6mo).

Show the 'tu' import/setup once (e.g., 'import tooluniverse as tu') so the inline code snippets are copy-paste executable, and consider adding the missing 'patent' trigger term context where patent questions are handled.

DimensionReasoningScore

Conciseness

The body is mostly efficient — dense tool parameter/return documentation Claude cannot know — but includes unnecessary or duplicated material: exclusivity codes (NCE/ODE/PED) are explained in both Phase 4 and the Reasoning Framework, the FAERS medicinalproduct param is noted twice, and the Reasoning Framework re-explains concepts Claude already knows (what an ANDA is, what Cmax/AUC/half-life are). This fits anchor 3 (mostly efficient, some unnecessary explanation or tightening possible) better than anchor 4.

3 / 5

Actionability

Highly actionable: every tool has exact parameter names, types, defaults, and return shapes, plus concrete calls and gotchas (UPPERCASE brand names, ttys="IN", overall_status as array). It falls short of anchor 5 because the Python snippets use an undefined 'tu' binding with no import/setup shown anywhere, so they are not fully copy-paste ready.

4 / 5

Workflow Clarity

The 8-phase workflow is clearly sequenced with an overview diagram, explicit cross-phase dependencies (search for UNII before get_substance, find class_id before get_class_members), and a Common Mistakes checklist. Verification steps exist but are implicit (e.g., 'check len(studies) > 0', read generics_available) rather than explicit validate-then-proceed checkpoints, matching anchor 4 rather than 5. The destructive/batch cap does not apply since all operations are read-only lookups.

4 / 5

Progressive Disclosure

No bundle files exist (no references/, scripts/, or assets/), and ~150 lines of per-tool API reference (params, return schemas, code aliases) are inlined in a single 280-line SKILL.md. Section headers and per-phase organization provide structure, but reference-grade material that belongs in a separate file is inline — matching anchor 3 rather than the well-split anchor 4.

3 / 5

Total

14

/

20

Passed

Description

83%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: it names concrete regulatory capabilities, includes an explicit 'Use for...' clause with jurisdiction-aware trigger scenarios, and stays in third person without fluff. Its weaknesses are minor — it claims EMA coverage the body does not deliver, omits patent/label terminology users naturally say, and slightly overlaps sibling drug-classification skills.

DimensionReasoningScore

Specificity

Lists several specific capabilities — 'FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways' — but coverage has minor gaps: EMA decisions are claimed with no backing tooling in the body, and label parsing, clinical trials, and pharmacovigilance (three of eight body phases) are unmentioned. This matches anchor 4 (several specific actions, minor gaps) rather than anchor 5 (comprehensive coverage).

4 / 5

Completeness

Clearly answers both 'what' (substance registry, classification, EMA decisions, generic status, exclusivity, NDA/BLA pathways) and 'when' via the explicit clause 'Use for jurisdiction-aware approval status (FDA vs EMA), generic vs brand availability, exclusivity expiry tracking, and regulatory pathway selection.' This matches anchor 5: explicit what AND when with concrete trigger phrases.

5 / 5

Trigger Term Quality

Good natural-term coverage: 'FDA', 'generic', 'Orange Book', 'ATC', 'NDA', 'approval', 'exclusivity' are terms users would naturally say. A few common terms are missing from the description — notably 'patent' (e.g., 'when does the patent expire'), 'drug label', and 'adverse reactions' — so it falls short of the comprehensive synonym coverage of anchor 5.

4 / 5

Distinctiveness Conflict Risk

The regulatory/approval niche (Orange Book, exclusivity, NDA/BLA, UNII) is mostly distinct with minimal conflict risk, but terms like 'ATC code' and 'drug class' overlap with sibling drug skills (e.g., mechanism-research), fitting anchor 4 rather than the fully distinct anchor 5.

4 / 5

Total

17

/

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

plugins/tooluniverse/skills/tooluniverse-drug-regulatory/SKILL.md

Reviewed

Table of Contents

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.