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Information Request Response Toolkit

Master the art of responding to FDA IRs, EMA queries, and PMDA questions with AI-powered draft automation

πŸ“– 12 min readβ€’Last updated: November 2025

Quick Reference: Global Agency IRs

πŸ‡ΊπŸ‡Έ FDA (United States)

Information Request (IR)
Review cycle questions
Complete Response Letter (CRL)
Formal rejection with deficiencies
⏱️ Response Time:
IR: 30 days (can request extension)
CRL: 6-12 months for resubmission

πŸ‡ͺπŸ‡Ί EMA (European Union)

Day 120 Questions (List of Questions)
First round assessment queries
Day 180 Questions
Follow-up after Day 120 responses
⏱️ Response Time:
Day 120: 60 days to respond
Day 180: 30-60 days (case dependent)

πŸ‡―πŸ‡΅ PMDA (Japan)

Shitsumon (θ³ͺ問)
Review queries from PMDA
Response Format
Detailed technical responses in Japanese/English
⏱️ Response Time:
Typically 1-2 months
Extension possible upon request

Anatomy of an FDA Information Request

πŸ“§ What's in an IR?

1
Reviewer Identification
Name, role (clinical, CMC, pharmacology), and division
2
Question Categorization
Organized by discipline (CMC questions, Clinical questions, etc.)
3
Specific Questions
Numbered questions with references to specific NDA sections
4
Response Deadline
Typically 30 days from issue date (may vary)

Common IR Categories

βš—οΈ

CMC (Chemistry, Manufacturing, Controls)

  • β€’ Clarification on manufacturing process
  • β€’ Additional stability data requested
  • β€’ Specification justification
  • β€’ Impurity qualification
  • β€’ Container closure system validation
🧬

Clinical

  • β€’ Efficacy endpoint clarification
  • β€’ Safety signal investigation
  • β€’ Subgroup analysis requested
  • β€’ Dosing rationale
  • β€’ Statistical methodology questions
πŸ§ͺ

Nonclinical (Pharmacology/Toxicology)

  • β€’ Genotoxicity study interpretation
  • β€’ Carcinogenicity findings
  • β€’ NOAEL determination
  • β€’ Reproductive toxicology
  • β€’ Safety pharmacology endpoints
πŸ“Š

Biopharmaceutics

  • β€’ Bioequivalence demonstration
  • β€’ Food effect study
  • β€’ Dissolution method validation
  • β€’ Biow aiver justification
  • β€’ PK/PD correlation

Winning IR Response Strategy

1

Understand the Question

Before drafting, ensure you fully understand what the reviewer is asking. Misinterpreting the question is the #1 cause of re-IRs.

πŸ’‘ Pro Tip:
Highlight key phrases in the question: "provide data", "justify", "clarify", "additional studies". Each requires a different response approach.
2

Locate Supporting Data

Cross-reference the NDA section mentioned in the IR. Gather all relevant data: studies, SOPs, validation reports.

πŸ€– How DossiAIr Helps:
AI automatically searches your entire dossier for relevant content based on the IR question keywords. Provides a list of potentially relevant sections and documents.
3

Draft Response Using SBAR Format

Situation-Background-Assessment-Recommendation structure ensures clarity and completeness.

Situation:
Restate the reviewer's question in your own words
Background:
Provide context from the original NDA submission
Assessment:
Present data, analysis, or justification
Recommendation:
Proposed action or conclusion
4

Review for Completeness

Every response must directly answer the question asked. Incomplete responses trigger follow-up IRs or CRLs.

🚨 Common Pitfalls to Avoid:
  • β€’ Answering a different question than asked
  • β€’ Providing insufficient data/justification
  • β€’ Contradicting previous submissions
  • β€’ Missing cross-references to supporting docs

AI-Powered IR Response with DossiAIr

⚑ 75% Faster Response Drafting

Traditional Process:
  • 1. Read IR (30 min)
  • 2. Search dossier manually (2-3 hours)
  • 3. Draft response (4-6 hours)
  • 4. Internal review cycles (1-2 days)
  • Total: 3-5 days per IR
With DossiAIr:
  • 1. Upload IR (5 min)
  • 2. AI finds relevant sections (instant)
  • 3. AI drafts SBAR response (30 min)
  • 4. Expert review & finalize (4-6 hours)
  • Total: 6-8 hours per IR

βœ… What DossiAIr Generates

  • β€’Cover letter with IR summary
  • β€’Question-by-question responses in SBAR format
  • β€’Cross-references to original NDA sections
  • β€’Appendices with supporting data tables/figures
  • β€’Updated eCTD modules (if submission required)

🎯 Intelligent Features

  • β€’IR classification (CMC, Clinical, Nonclinical)
  • β€’Semantic search across entire dossier
  • β€’Regulatory terminology consistency check
  • β€’Response completeness scoring
  • β€’Version control and audit trail

IR Response Best Practices

βœ… DO:

  • β€’Respond to every sub-question within the IR
  • β€’Provide clear cross-references to NDA sections
  • β€’Use tables, figures, and appendices to support your response
  • β€’Request extension if needed (before deadline)
  • β€’Offer to schedule a Type A meeting if question is complex

❌ DON'T:

  • β€’Provide vague or evasive answers
  • β€’Introduce new data without context or justification
  • β€’Argue with the reviewer or challenge their expertise
  • β€’Miss the response deadline without requesting extension
  • β€’Submit IR response without internal SME review

Respond to IRs 75% Faster

See how DossiAIr can transform your Information Request response workflow