Dimension	IND (Investigational New Drug)	NDA (New Drug Application)
Common Chinese term	Clinical Trial Application	New Drug Marketing Application
Development stage	Preclinical → Clinical stage	End of clinical development → Marketing stage
Purpose	Authorization to administer an investigational drug to humans	Authorization to market and sell a drug
Submission timing	Before first-in-human (FIH) studies	After completion of Phase III trials
Mandatory	Required before initiating clinical trials	Required before marketing approval
Commercialization allowed	❌ Not allowed	✅ Allowed
Primary regulatory focus	Subject safety	Benefit–risk balance, efficacy, and safety

Briefing documents are question-driven materials provided in advance of regulatory meetings to support efficient discussion and obtain regulatory advice or agreement.

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Typical use cases

Most commonly used for formal regulatory interactions, such as:

• FDA: Pre-IND, End-of-Phase (EOP) meetings, Pre-NDA meetings

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Typical contents

While the structure varies by meeting type, briefing documents usually include:

1. Executive Summary
• Program background, mechanism of action, development status
• Purpose of the meeting
2. Key supporting data
• Relevant nonclinical data (pharmacology, toxicology)
• Available clinical data (if applicable)
3. Proposed development plans
• Planned study designs
• Dose selection rationale, endpoints
4. CMC information (if relevant)
• Manufacturing process overview
• Quality or change-related considerations
5. Key questions for the agency ⭐
• Clearly framed questions seeking regulatory feedback
• Often structured as yes/no or multiple-option questions

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Regulatory purpose

From a regulatory perspective, briefing documents are used to:

• Minimize time spent explaining background during the meeting
• Allow reviewers to identify risks and concerns in advance
• Ensure the meeting focuses on decision-critical topics

In practice, many regulatory positions are formed during the review of the briefing documents, before the meeting itself.

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How briefing documents differ from other materials

Document	Primary purpose	Question-driven
IND / NDA submission	Formal regulatory review	❌
Briefing documents	Meeting support and regulatory advice	✅
Slide deck	Oral presentation	Partially
Meeting minutes	Post-meeting record	❌

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Key characteristics

• Not a comprehensive regulatory submission
• Focused on rationale, risks, and decisions
• Concise and structured
• The quality of the questions largely determines the value of the meeting

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Summary

Briefing documents are decision-support materials prepared specifically for regulatory meetings, designed to facilitate focused discussion and clear regulatory feedback.