Meetings Materials on FDA's website

Because of the FDA Transparency Initiative, the meetings, conferences, and workshops sponsored or co-sponsored by FDA are not open to the public. Shortly after the meetings, conferences, and workshops, the materials and webcasts are usually available to the public. This is a good step forward.

The list of meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER) can be found at the following website:

Meetings, Conferences, & Workshops (Drugs)

For example, for several public meetings that I am interested in, the meeting materials are all available to the public on the website. 

• Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction
• Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases
• Public Meeting on Meta-Analyses of Randomized Controlled Clinical Trials for the Evaluation of Risk to Support Regulatory Decisions

Periodically, FDA organizes the Advisory Committee (AC) meetings. While FDA may or may not follow the recommendations from Advisory Committees, the materials presented at the advisory committee meetings are always important. Sometimes, the statistical issues such as the endpoint selection, missing data handling, interpretation of the safety results are extensively discussed during the AC meeting and in the meeting materials. Fortunately, the AC meeting materials are usually posted on the web and sometimes, the webcasts are available too. 

Advisory Committees & Meeting Materials