Regulatory agencies encourage active communication with drug developers at various stages. Effective communication not only reduces the risks and costs of drug development but also significantly accelerates the drug development process. To obtain targeted advice from regulatory agencies during meetings, applicants need to carefully plan the meeting topics and materials and efficiently communicate with the regulatory agencies. Both the FDA and NMPA have established regulations and guidelines to specify and guide the formal meeting procedures for different types of products. Here are some types of meetings available to applicants:
Formal Meetings with the FDA for Prescription Drug Products
>INTERACT Meetings
>Type A Meetings
>Type B Meetings (e.g., pre-IND, pre-NDA, pre-BLA meetings)
>Type B EOP Meetings (e.g., EOP1, EOP2 meetings)
>Type C Meetings
>Type D Meetings
Formal Meetings with the FDA for Complex Generic Drug Products
>Product Development Meetings
>Pre-Submission Meetings
>Mid-Cycle Review Meetings
>Enhanced Mid-Cycle Review Meetings
>Post-CRL Scientific Meetings
Formal Meetings with the FDA for Biosimilar Products
>BIA Meetings
>BPD Type 1 Meetings
>BPD Type 2a Meetings
>BPD Type 2b Meetings
>BPD Type 3 Meetings
Formal Meetings and Communication Under NMPA
>Class I
>Class II
>Class III meetings
>General Technical Issue Communications
Humphries conducts an average of 3-4 formal meetings with various regulatory agencies on behalf of clients every month. Humphries's project teams consist of former FDA/CDE reviewers, senior CMC/non-clinical/clinical/regulatory experts, and experienced project managers who can assist clients comprehensively before, during, and after meetings to achieve meeting objectives. Here are the specific services Humphries provides:
01. Developing Communication Strategies
Based on preliminary project data, future plans, product categories, development stages, potential risk points, and the Sponsor's clinical/business objectives, Humphries selects appropriate meeting types and develops feasible meeting application plans and schedules.
02. Writing and Organizing Meeting Materials
Humphries is well-versed in the application procedures and material requirements for different meetings. We can assist the Sponsor in selecting and drafting meeting questions, compiling, and organizing meeting materials. Targeted questions and meeting materials can help the Sponsor obtain effective advice from regulatory agencies.
03. Conducting Meeting Rehearsals
For video/telephone conferences and in-person meetings, thorough meeting rehearsals are essential to enhance the efficiency of formal meetings and ensure smooth proceedings. Humphries organizes one or multiple meeting rehearsals with the Sponsor to review the formal meeting process and schedule, discuss response strategies, and develop contingency plans, ensuring the successful conduct of formal meetings.
04. Representing the Sponsor in On-Site Communications
Humphries's consultants have extensive experience in meetings and excellent communication skills. We can represent the Sponsor in team introductions, presenting questions or viewpoints, and responding to questions or opinions from regulatory agencies during formal meetings, maximizing the protection of the Sponsor's interests and achieving the expected meeting objectives.
05. Follow-up and Opinion Interpretation
Humphries can accurately interpret regulatory agency suggestions and assist the Sponsor in formulating necessary response measures and strategies based on these suggestions. For specific issues, Humphries can also assist the Sponsor in making further confirmation or discussion requests to regulatory agencies, ensuring comprehensive support for your project.
