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Regulatory Prompt Guide

The Regulatory Prompt Guide

A Comprehensive Handbook for Crafting Effective FDA & Global Regulatory Research Queries

First Edition

Leaf Intelligence

Chapter I

The Art of Regulatory Inquiry

Understanding how to communicate with AI for regulatory research

Welcome to the Leaf Intelligence Regulatory Prompt Guide. This handbook will teach you the principles of crafting effective queries that yield precise, comprehensive, and actionable regulatory intelligence.

Why Prompts Matter

The quality of your question directly determines the quality of your answer. A well-crafted prompt acts as a precise instrument, cutting through vast regulatory databases, FDA guidance documents, and global compliance requirements to extract exactly what you need.

💡
Think of prompting as giving directions to a highly capable regulatory affairs specialist. The clearer your directions, the better the results.

The Golden Rules

  • Be Specific — Vague questions yield vague answers
  • Provide Context — Help the AI understand your regulatory situation
  • State Your Goal — What regulatory decision do you need to make?
  • Choose the Right Depth — Quick Search vs Deep Research
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Chapter II

Quick Search Mastery

Fast answers for straightforward regulatory questions

Quick Search is your go-to for factual queries, definitions, and straightforward regulatory questions. It scans the knowledge base rapidly and returns concise, accurate information in approximately 30 seconds.

When to Use Quick Search

  • Regulatory definitions and terminology
  • Specific CFR requirements
  • Quick fact-checking on guidance documents
  • Simple procedural questions
  • Filing deadlines and timelines

Effective Quick Search Prompts:

✓ What is the definition of a 505(b)(2) application?
✓ What are the FDA's requirements for biosimilar naming?
✓ What is the timeline for EMA's centralized procedure?
✓ What is the PDUFA user fee for FY2024?
⚡
Quick Search works best with direct questions that have definitive answers. Save complex analysis for Deep Research.
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Chapter III

Deep Research Excellence

Comprehensive analysis for complex regulatory questions

Deep Research is designed for complex regulatory questions that require multi-source analysis, comparative studies, and thorough examination. Allow approximately 10 minutes for comprehensive results.

When to Use Deep Research

  • Regulatory pathway comparisons (505(b)(1) vs 505(b)(2) vs ANDA)
  • Strategic development questions
  • Complex compliance gap analysis
  • Multi-jurisdictional requirements (FDA vs EMA vs PMDA)
  • Precedent analysis from similar approvals

Effective Deep Research Prompts:

✓ Compare the FDA and EMA approval pathways for cell and gene therapies, including timeline differences, key requirements, and recent precedents.
✓ What are the strategic considerations for choosing between a 505(b)(1) and 505(b)(2) pathway for a modified-release formulation of an existing API?

Structuring Complex Queries

For best results, break down your question into clear components: What do you need to know? Why? What regulatory decision will this inform?

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Chapter IV

FDA-Specific Queries

Mastering prompts for US regulatory intelligence

Drug Development (CDER)

✓ What CMC requirements apply to a monoclonal antibody BLA submission?
✓ What are the eligibility criteria for Breakthrough Therapy designation for [indication]?
✓ What clinical endpoints has FDA accepted for [therapeutic area] in recent approvals?

Medical Devices (CDRH)

✓ What predicate devices have been used for [device type] 510(k) clearances?
✓ What are the special controls for Class II [device category]?
✓ Compare De Novo vs 510(k) pathway for a novel AI/ML diagnostic device.

Biologics (CBER)

✓ What are the potency assay requirements for [biologic type]?
✓ What does FDA require for comparability studies after manufacturing changes?
🏛️
Include the relevant FDA center (CDER, CDRH, CBER) when possible to get more targeted responses.
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Chapter V

Global Regulatory Queries

Multi-jurisdictional and international prompts

EMA / European Union

✓ What are the differences between centralized, decentralized, and mutual recognition procedures?
✓ What are EMA's requirements for pediatric investigation plans (PIPs)?
✓ How does EU MDR affect legacy medical devices?

Comparative / Multi-Regional

✓ Compare FDA, EMA, and PMDA requirements for [specific aspect] of [product type].
✓ What ICH guidelines apply to [topic] and how do regional implementations differ?
✓ What is the regulatory pathway for [product] in China (NMPA) vs US (FDA)?

Emerging Markets

✓ What are Brazil ANVISA's requirements for biological product registration?
✓ What reference country options exist for ASEAN pharmaceutical registration?
🌍
For global queries, specify which jurisdictions you need and what aspects to compare (timelines, data requirements, fees, etc.).
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Chapter VI

Proven Prompt Formulas

Templates for consistent regulatory results

The Context + Question Formula

Provide relevant background before your question to get tailored responses.

✓ "We're developing a biosimilar to [reference product] with a different delivery device. What are the FDA's requirements for demonstrating interchangeability, and does the device difference affect this?"

The Comparison Formula

When comparing options, specify what aspects matter to your decision.

✓ "Compare expedited FDA pathways (Fast Track, Breakthrough, Accelerated Approval, Priority Review) for oncology drugs in terms of eligibility criteria, benefits, and obligations."

The Checklist Formula

Ask for structured, actionable outputs for compliance.

✓ "What documentation is required for a Pre-IND meeting request package? Provide as a submission checklist with FDA references."

The Precedent Formula

Learn from similar approved products.

✓ "What clinical trial designs and endpoints were used in recent FDA approvals for [indication]? Include specific product examples."
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Chapter VII

Submissions & FDA Meetings

Queries for regulatory interactions

Pre-Submission Meetings

✓ What are the requirements for a Pre-IND meeting request and what should the briefing document contain?
✓ What is the difference between Type A, Type B, and Type C FDA meetings?
✓ How should questions be structured for an End-of-Phase 2 meeting?

eCTD Submissions

✓ What are the Module 3 CMC requirements for [dosage form]?
✓ What formatting requirements apply to eCTD submission documents?
✓ What are common deficiencies in [section] that lead to Refuse to File?

Post-Approval

✓ What changes require a Prior Approval Supplement (PAS) vs CBE-30 vs Annual Report?
✓ What are REMS requirements for [drug class]?
📋
For submission queries, always specify the product type, dosage form, and therapeutic area when relevant.
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Chapter VIII

CMC & Manufacturing

Chemistry, Manufacturing, and Controls queries

Drug Substance

✓ What are FDA's expectations for control strategy documentation in Module 3.2.S?
✓ What ICH guidelines apply to impurity qualification for [API type]?
✓ What starting material justification is needed for a synthetic API?

Drug Product

✓ What dissolution specifications are expected for [dosage form]?
✓ What container closure system data is required for [product type]?
✓ What stability studies are needed for a shelf-life extension supplement?

Manufacturing Changes

✓ What comparability data is required for a manufacturing site change?
✓ How do I determine if a process change is reportable under SUPAC?
🔬
Include ICH guideline references (Q8, Q9, Q10, Q11, Q12) when asking about CMC topics for more precise guidance.
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Chapter IX

Clinical & Nonclinical

Development program queries

Nonclinical / Toxicology

✓ What nonclinical studies are required to support first-in-human trials for [modality]?
✓ What are ICH S9 requirements for oncology products?
✓ When is a juvenile toxicity study required?

Clinical Development

✓ What clinical pharmacology studies are expected for a 505(b)(2) NDA?
✓ What are FDA's recommendations for adaptive trial designs in [indication]?
✓ What patient-reported outcome measures has FDA accepted for [condition]?

Special Populations

✓ What pediatric study requirements apply under PREA for [indication]?
✓ What hepatic/renal impairment studies are recommended for [drug class]?
🧪
For clinical queries, specify the phase, indication, and patient population to get development-stage appropriate guidance.
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Chapter X

Common Pitfalls

Mistakes to avoid in regulatory queries

Pitfall #1: Being Too Vague

✗ Tell me about FDA regulations.
✓ What are the FDA's CMC stability requirements for parenteral drug products per ICH Q1A?

Pitfall #2: Assuming Context

✗ What's the timeline?
✓ What is the typical FDA review timeline for a standard 505(b)(2) NDA submission?

Pitfall #3: Multiple Unrelated Questions

✗ What's a 510(k) and also tell me about EU MDR and what's pharmacovigilance?
✓ Ask each question separately for focused, detailed answers.

Pitfall #4: Missing Product Context

✗ What clinical trials are needed?
✓ What clinical trials are typically required for a biosimilar to a monoclonal antibody in oncology?

Pitfall #5: Wrong Research Depth

Using Quick Search for complex strategic questions, or Deep Research for simple definitions, wastes time and reduces quality.

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Chapter XI

Advanced Techniques

Elevating your regulatory research

Follow-up Questions

Build on previous answers to dive deeper. The AI remembers your conversation context.

Initial: "What is the Breakthrough Therapy designation?"
Follow-up: "What clinical evidence is typically needed to qualify for [my indication]?"
Follow-up: "What are the FDA interaction benefits once designated?"

Scenario-Based Queries

Present hypothetical situations for strategic guidance.

✓ "If a Phase 2 trial shows promising efficacy but limited long-term safety data, what regulatory strategies could enable accelerated approval while managing post-market requirements?"

Request Specific Formats

  • "Summarize the key requirements in bullet points..."
  • "Create a comparison table of [options]..."
  • "Provide a step-by-step regulatory pathway..."
  • "List the pros and cons of each approach..."
  • "Create a timeline with key milestones..."
🎯
The more specific your request, the more actionable the response. Don't hesitate to ask for exactly what you need.
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Chapter XII

Competitive Intelligence

Market and competitor analysis queries

Approval History

✓ What products have been approved for [indication] in the past 5 years and through which pathways?
✓ What were the pivotal trial designs for recently approved [drug class] products?

Pipeline Analysis

✓ What products are in late-stage development for [indication]?
✓ Which companies have received Breakthrough Therapy designation for [condition]?

Patent & Exclusivity

✓ What exclusivity protections apply to [reference product] and when do they expire?
✓ What Orange Book patents are listed for [drug]?

Labeling & Claims

✓ What efficacy claims are in the approved labeling for [competitor product]?
✓ Compare the boxed warnings across [drug class] products.
📊
Combine competitive queries with regulatory pathway questions to inform your development strategy.
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Reference

Quick Reference Card

Keep these principles at hand

⚡ Quick Search (~30 seconds)

  • Definitions & terminology
  • Specific CFR/guidance requirements
  • Factual questions with definitive answers
  • Simple procedures & timelines
  • User fee amounts & deadlines

🔬 Deep Research (~10 minutes)

  • Complex pathway comparisons
  • Strategic development analysis
  • Multi-jurisdictional requirements
  • Comprehensive precedent reviews
  • Gap analyses & risk assessments

✅ Prompt Checklist

  • ☐ Is my question specific enough?
  • ☐ Have I provided product/indication context?
  • ☐ Is my regulatory goal clear?
  • ☐ Am I using the right research depth?
  • ☐ Have I specified my desired output format?
  • ☐ Did I mention relevant jurisdictions?
🚀
Practice makes perfect. The more you use Leaf Intelligence, the more intuitive effective regulatory prompting becomes.
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