The slide is a title slide titled "FDA Nasal Spray & Inhalation CMC Guidance." Its subtitle describes it as "Chemistry, Manufacturing, and Controls Documentation for Regulatory Professionals."

FDA Nasal Spray & Inhalation CMC Guidance

Chemistry, Manufacturing, and Controls Documentation for Regulatory Professionals

Source: FDA Guidance for Industry

This agenda slide outlines the structure of the presentation, starting with Introduction and Background. It continues with Drug Product Requirements, Characterization Studies, Labeling Considerations, and ends with Key Takeaways.

Presentation Agenda

1. Introduction
2. Background
3. Drug Product Requirements
4. Characterization Studies
5. Labeling Considerations
6. Key Takeaways

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Drug Products — CMC Documentation

This section header slide, titled "Introduction" and numbered "01", introduces the topic. It features a subtitle providing an overview of the FDA Guidance scope for CMC of Nasal and Inhalation Drug Products.

Introduction

01

Introduction

Overview of FDA Guidance Scope for Nasal and Inhalation Drug Products CMC

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — CMC Documentation

This slide provides background on the historical context and evolution of CMC requirements, along with their applicability to nasal sprays and inhalation drug products. It also references prior guidances and regulations.

Background

• Historical context and evolution of CMC requirements
• Applicability to nasal sprays and inhalation drug products
• References to prior guidances and regulations

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — CMC Documentation

The slide outlines key drug product requirements, including formulation and composition details, container closure systems, manufacturing process controls, and stability testing protocols. It emphasizes essential elements for ensuring product quality and compliance.

Drug Product Requirements

• Formulation and composition details
• Container closure systems
• Manufacturing process controls
• Stability testing protocols

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Drug Products — CMC Documentation

The slide "Characterization Studies" details physicochemical properties on the left, including particle size distribution, spray pattern, plume geometry, droplet size, and morphology, to ensure uniformity, reproducibility, and performance consistency of nasal and inhalation drug products. On the right, it covers in vitro performance and controls such as in vitro release, extractables/leachables, and microbial controls, validating device functionality, safety from impurities, and sterility to meet regulatory standards.

Characterization Studies

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — CMC Documentation

The slide "Labeling Considerations" outlines key elements for effective labeling, including storage and handling instructions, device-specific claims, CMC-related safety information, and efficacy labeling requirements. It emphasizes incorporating these aspects to ensure comprehensive and compliant product labeling.

Labeling Considerations

• Include storage and handling instructions
• Incorporate device-specific claims
• Address CMC-related safety information
• Highlight efficacy labeling requirements

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Drug Products — CMC Documentation

The slide's key takeaways emphasize that comprehensive CMC data ensures product quality, with a focus on device-drug interaction studies and consulting full guidance for submissions. It prioritizes robust CMC for successful submissions and invites questions.

Key Takeaways

**Key Takeaways:

• Comprehensive CMC data ensures product quality.
• Focus on device-drug interaction studies.
• Consult full guidance for detailed submissions.

Thank you! Questions?**

Prioritize robust CMC for successful submissions.

Source: FDA Guidance for Industry: Nasal Spray and Inhalation Drug Products — CMC Documentation