FDA Laws, Regulations, and Guidance Documents
Discussion of the legal framework within which CBER operates; introduction to and historical overview of statutes relevant to CBER’s regulatory activities; FDA rulemaking; and FDA guidance documents.
Good Guidance Practices
Discussion of FDA’s development of draft and final guidance documents.
An overview of CBER’s decision process on regulatory responsibility for products within the Center.
CBER Advisory Committees
Overview of the FDA Advisory Committee Program, to include areas under advisement, committee structure, member screening, and public forums.
Addressing Pandemic Influenza Preparedness
Discussion of the 2009 H1N1 pandemic, and includes discussion on licensure of H1N1 vaccines, regulatory pathways for pandemic vaccine licensure, and emergency use authorizations.