| name | pharma-reg-summary |
| title | Pharmaceutical Regulation Compliance Summary |
| description | Generates structured pharmaceutical regulatory compliance summaries covering FDA approval pathways, patent/IP intersections (Orange Book, Hatch-Waxman), and marketing restrictions (off-label, DTC, Anti-Kickback). Use when preparing FDA compliance overviews, submission readiness assessments, or promotional compliance reviews. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/pharma-reg-summary |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
Pharmaceutical Regulation Compliance Summary
Produces an actionable regulatory compliance summary structured around FDA frameworks, patent/IP strategy, and promotional compliance.
Prerequisites
Gather before starting:
- Product portfolio — marketed products, pipeline compounds, therapeutic areas
- Regulatory filings — pending NDAs/ANDAs/BLAs, active INDs, post-approval commitments
- Commercial activities — speaker programs, DTC campaigns, consulting arrangements
- Compliance history — warning letters, consent decrees, audit findings
Quick Start
Structure every summary into three sections:
- Drug Approval & Post-Market Obligations — pathway requirements, safety reporting, PMRs/PMCs
- Patent & IP Regulatory Intersections — Orange Book, exclusivity, Hatch-Waxman
- Marketing & Promotional Compliance — off-label rules, financial compliance, DTC advertising
Core Workflow
1. Drug Approval & Post-Market Obligations
| Pathway | Requirements | Pitfalls |
|---|
| NDA 505(b)(1) | Full clinical data, CMC, labeling | Data integrity gaps, incomplete safety DBs |
| ANDA 505(j) | Bioequivalence, Para IV certs | Improper BE design, cert errors |
| BLA 351(a) | Biosimilarity/interchangeability | Analytical similarity gaps, immunogenicity |
| Expedited (BT/FT/AA) | Post-market confirmatory requirements | Missing confirmatory trial milestones |
Per-product checklist:
2. Patent & IP Regulatory Intersections
