In what context does a Type C meeting typically occur?

A Type C meeting is typically convened when a sponsor has a specific proposal or question related to the development or regulatory requirements of a product, rather than for broad or non-specific discussions. These meetings generally focus on issues that might impact the design of clinical trials, product development plans, or other aspects of regulatory submissions.

In the context of regulatory affairs, Type C meetings are often intended for providing advice on development plans and ensuring that sponsors and the FDA are aligned on critical aspects before proceeding with significant steps in product development. This makes them a useful platform for addressing specific queries regarding study designs, regulatory pathways, or data requirements needed to support a filing.

The other contexts presented serve different purposes. A meeting where the FDA seeks market feedback would not typically classify as a Type C meeting, since that is more aligned with Type B meetings, which are usually about obtaining input on broader product development strategies. Urgent approval protocols and post-market evaluations relate to different phases of the product lifecycle and regulatory processes, which do not align with the specific focus of Type C discussions.