Results for “fda-approval”

Screen products for FDA, EPA, USDA, CPSC, FCC, and other government agency requirements using AskRosetta. Use when checking regulatory compliance for US imports.

Drafts a Receipt of Franchise Disclosure Document proving FTC Franchise Rule compliance under 16 C.F.R. § 436. Produces an execution-ready acknowledgment with franchisee identification, delivery date, FDD version, exhibit inventory, and dual signature blocks. Use when creating FDD receipts, franchise disclosure acknowledgments, or Item 19 FPR attestations.

Prepares for FDA QSR audits by asking six forcing questions covering complaints, process validation, DHRs, CAPAs, labeling, and Form 483 history.

Drafts U.S. HACCP plans for food production under FDA or USDA regimes. Triggers on requests involving HACCP plans, food safety plans, hazard analysis, critical control points, FSMA compliance, seafood HACCP (21 CFR 123), or meat/poultry HACCP (9 CFR 417).

Federal acquisition compliance auditor for the active Theseus workspace, backed by live FAR/DFARS text via the vendored `ecfr` MCP. USE WHEN the user asks to audit FAR/DFARS clause coverage, validate that cited clauses actually exist in eCFR (catch fabricated or typo'd numbers), check whether a cited clause has been amended since the solicitation issued, validate regulatory references (NIST SP, DAFI, MIL-STD), check that every "shall" requirement has a deliverable, find missing compliance artifacts, audit proposal_instruction ↔ evaluation_factor coverage (UCF Section L↔M or non-UCF equivalent — FAR 16 task orders, FOPRs, BPA calls, OTAs), or "are we compliant with the proposal instructions?". Cross-references the workspace's clause / regulatory_reference / requirement / deliverable / compliance_artifact entities against live eCFR and flags gaps with severity. Format-agnostic. DO NOT USE FOR drafting compliant prose (use proposal-generator) or extracting clauses (Theseus pipeline does that automatically).

Query the openFDA API for drugs, medical devices, adverse event reports, recalls, regulatory submissions (510k, PMA), and substance identification (UNII). Use when searching FDA safety data, pharmacovigilance and adverse-event signals, device clearances, drug labels, or recall records for regulatory data analysis and safety research. Part of the AlterLab Academic Skills suite.

Applies the FedRAMP framework to identify, assess, and mitigate security risks in systems, processes, and data handling.

UAT Sign-off

Validates App Store submission readiness, submits prepared versions, and monitors review status using current asc commands.

Use this skill when a driver does not meet federal medical standards and needs to apply for a variance. Covers application steps, required documentation, and review timeline.

飞书审批：查询和处理审批待办/已办/实例，搜索可发起审批定义、查看定义详情并发起原生审批实例。当用户要处理审批任务、查看审批实例、搜索或发起审批时使用。审批待办不是飞书任务；非审批类待办走 lark-task。不负责创建审批定义；三方审批定义不走原生提单。

Design, review, or troubleshoot Salesforce Approval Processes, covering entry criteria, approver routing, record locking, and recall behavior.

Creates an approval-gated product requirements document or decomposes an approved PRD into a traceable roadmap, covering product-level problems, new initiatives, multi-feature scope, PRDs, release outcomes, and roadmap planning.

Designs an approval-gated feature specification from approved requirements, covering architecture decisions, component boundaries, quality constraints, and definition of done.

Use only for developer-facing products; audit docs for quickstart clarity, examples, API reference, troubleshooting, and migration paths

Use this skill when the user asks about FCRA adverse action procedures — what to do when a background check (MVR, criminal, drug test) returns information that may lead to denying employment or terminating a CDL driver. Covers the 5-business-day pre-adverse-action notice, FCRA Summary of Rights, final adverse action notice, state-specific add-ons (CA, NY, etc.), and how to handle disputes. Cite 15 USC § 1681 (FCRA) and 49 CFR 391.

Schema validation for notes. Checks against domain-specific templates. Validates required fields, enum values, description quality, and link health. Non-blocking — warns but doesn't prevent capture. Triggers on "/validate", "/validate [note]", "check schema", "validate note", "validate all".

Stops fantasy approvals, evidence-based certification - Default to "NEEDS WORK", requires overwhelming proof for production readiness

Conduct authorized iOS application security assessments using Frida, Objection, and static analysis to evaluate app security posture against OWASP MASTG standards.

Drafts a U.S. franchise-focused confidentiality and non-disclosure agreement protecting franchisor trade secrets, operational manuals, financial data, marketing strategies, and supplier terms during pre-franchise evaluation. Use when preparing an NDA for prospective franchisees, pre-FDD disclosures, franchise due diligence, or confidentiality agreements covering franchise system information.

Implements Children's Online Privacy Protection Act (COPPA) compliance under 16 CFR Part 312. Covers verifiable parental consent methods including signed forms, credit card verification, government ID, knowledge-based authentication, and video call. Includes FTC safe harbor programs and enforcement actions. Keywords: COPPA, FTC, children, parental consent, safe harbor, verifiable consent.

Use only for developer-facing products; plan adoption loops, examples, templates, community, and proof artifacts

Executes approved Flow plans one atomic task at a time with test-first implementation, fresh verification, blocker handling, and durable evidence.

Guides a structured interview and repository research to clarify feature requirements, classify scope, and produce context artifacts for approval before design.

Check post-launch adoption for a published ORD package and recommend iterate, graduate, or archive

NIH grant research skill for clinical researchers. Grill-me intake (research idea + career stage + preliminary data + environment + submission posture + known institute targets) locks down the funding strategy before any search runs. Runs a 5-facet Consensus positioning analysis (with draft Significance/Innovation language), maps the research to the right NIH institutes and study sections via RePORTER, finds NOSIs and funded overlap, and produces an editable Word document (.docx) with budget/scope-aware mechanism recommendations, submission timelines, and a mandatory program officer recommendation. Use when the user asks about research funding or makes any grant-related request (e.g., 'grants for [topic]', 'find grants for my research idea', 'what grants match my research', 'help me find NIH funding', 'grant opportunities for my research'). NIH-only scope — non-NIH funders (PCORI, DOD CDMRP, VA, foundations) are out of scope and flagged at intake.

Implementation guide for ePrivacy Directive compliant double opt-in email consent. Covers confirmation email workflow design, token expiration handling, record-keeping requirements, suppression list management, and integration with CAN-SPAM Act and CASL requirements for multi-jurisdiction compliance.

Centralized JSON validation for AGENT_SUCCESS_CRITERIA with defensive parsing and injection attack prevention (CVSS 8.2)

Use to build PNAS's Data Availability Statement and deposition plan — mandatory deposition of data in an approved repository at submission, accession numbers/DOIs, public + archived code, and materials sharing. "Available on request" is not sufficient for primary data.

Use this skill when the user asks about the FMCSA Drug & Alcohol Clearinghouse — full vs limited query, pre-employment vs annual query, query credit purchasing, who has access (employers, drivers, MROs, SAPs, state licensing agencies), reporting violations to the Clearinghouse, the "prohibited" status workflow, consent forms, or how to register/use the clearinghouse.fmcsa.dot.gov portal. Cite 49 CFR 382.701-727.

针对医疗隐私和安全工作的HIPAA特定入口点。当任务明确围绕HIPAA、PHI处理、受保实体、BAA、违规态势或美国医疗合规要求时使用。

Combined verification — recite (description quality via cold-read prediction) + validate (schema compliance) + review (health checks). Use as a quality gate after creating notes or as periodic maintenance. Triggers on "/verify", "/verify [note]", "verify note quality", "check note health".

Read-only audit of product-analytics instrumentation: event taxonomy, funnel completeness, consent-gated firing, dead/duplicate/phantom events. Use when "audit our analytics", "are we tracking the right events", "funnel instrumentation", or before iterate-post-launch. PostHog/Amplitude/Mixpanel/GA4.

Imported skill approval from langchain

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