In 2019, the FDA Center for Drug Evaluation and Research (CDER) established an Advisory Committee workstream for its New Drugs Regulatory Program to promote efficient and excellent advisory committee meetings that provide well-informed, clear, and consistent expert advice.
The Advisory Committee workstream started by focusing on three areas of advisory committee meeting planning where clear and streamlined policies, processes and resources would be helpful for FDA staff. These include clarifying when an advisory committee meeting is appropriate, finding ways to streamline the process for recruiting and retaining experts on committees, and developing accessible resources for FDA review teams to improve the development of high-quality FDA meeting materials and day-of execution.
The workstream is developing a range of resources, including:
- A tool containing a series of questions to assist review teams in determining whether an advisory committee meeting is appropriate. In CDER, decisions about whether to go to an advisory committee are made by the clinical division and office leadership within the Office of New Drugs and with input from CDER leadership, when appropriate.
- An educational reference guide for CDER staff on recruiting advisory committee experts, technology/knowledge management platforms for identifying potential advisory committee experts and assessing potential conflicts of interest, and learning modules for advisory committee members (see below).
- A template to help staff efficiently produce a streamlined advisory committee briefing document that focuses on the most pertinent information, while helping ensure a well-informed discussion of the issues.
Free, online, on-demand regulatory science learning modules that provide an overview of advisory committee meetings and cover topics related to common issues discussed at human drug advisory committee meetings. Additional modules will be added periodically.
Click on the following links to view modules: