A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Specific Aspects of FDA Guidance on CFG Requests: A Comprehensive Overview | RegDesk

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of drugs, medical devices, and other healthcare products in the United States. To achieve this, the FDA provides guidance to manufacturers and sponsors on various aspects of the regulatory process. One such aspect is the FDA’s guidance on Controlled Correspondence (CC) and Formal Meetings (FM) with the FDA.

Controlled Correspondence refers to written communication between the FDA and industry stakeholders, such as manufacturers, sponsors, or applicants. It allows for the exchange of information on specific topics related to the development, approval, or post-approval of a product. On the other hand, Formal Meetings are face-to-face or teleconference meetings between the FDA and industry stakeholders to discuss specific issues related to a product’s development or regulatory pathway.

The FDA has issued comprehensive guidance on Controlled Correspondence and Formal Meetings, outlining the procedures and requirements for requesting and conducting these interactions. This guidance aims to provide clarity and transparency to industry stakeholders, ensuring that their questions are addressed promptly and efficiently.

One important aspect of the FDA’s guidance is the requirement for a written request when seeking Controlled Correspondence or Formal Meetings. The request should include specific details about the purpose of the interaction, the questions or issues to be discussed, and any supporting documentation. This helps the FDA understand the nature of the request and allocate appropriate resources for review.

The guidance also provides information on the timelines for FDA responses to these requests. For Controlled Correspondence, the FDA aims to respond within 60 calendar days, while for Formal Meetings, the response time may vary depending on the type of meeting requested. This ensures that industry stakeholders receive timely feedback and guidance from the FDA.

Another important aspect covered in the guidance is the types of issues that can be addressed through Controlled Correspondence or Formal Meetings. These include questions related to product development, regulatory requirements, labeling, clinical trial design, manufacturing processes, and post-marketing commitments. The FDA encourages industry stakeholders to use these interactions to seek clarification and guidance on complex or ambiguous issues.

The guidance also outlines the procedures for scheduling and conducting Formal Meetings. It provides information on the different types of meetings, such as Type A, Type B, and Type C meetings, which are categorized based on the urgency and complexity of the issues to be discussed. The guidance also explains the roles and responsibilities of both the FDA and industry stakeholders during these meetings.

Furthermore, the guidance emphasizes the importance of preparing adequately for Controlled Correspondence and Formal Meetings. It advises industry stakeholders to provide clear and concise questions or issues for discussion, along with any relevant supporting documentation. This helps facilitate a productive and focused interaction between the FDA and industry stakeholders.

In conclusion, the FDA’s guidance on Controlled Correspondence and Formal Meetings provides a comprehensive overview of the procedures and requirements for requesting and conducting these interactions. It ensures that industry stakeholders have a clear understanding of the process and can effectively engage with the FDA to address their questions and concerns. By following this guidance, manufacturers, sponsors, and applicants can navigate the regulatory landscape more efficiently, ultimately leading to safer and more effective healthcare products for patients.