What is the purpose of a Type B meeting?

The purpose of a Type B meeting is primarily to hold pre-investigational drug discussions. These meetings are integral to the drug development process, specifically tailored for interactions between the sponsor and the regulatory authority, such as the FDA.

During a Type B meeting, sponsors can gather advice on various development plans and approaches related to their investigational new drugs. It allows for substantive dialogue on crucial topics, which may include the overall development program, proposed clinical study designs, and specific regulatory requirements that the sponsor must address before proceeding with the clinical investigation phase.

Type B meetings are essential for establishing a shared understanding of the sponsor’s objectives and expectations as well as regulatory perspectives, contributing to the efficient progression of drug development. They are commonly scheduled at pivotal points in the product development lifecycle, such as confirming trial designs or discussing the regulatory pathway.

This context emphasizes the role of Type B meetings in supporting sponsors to clarify and refine their plans, thereby ensuring they are well-prepared to meet regulatory standards as they advance their drug candidates.