This workshop, provides a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and obtain a basic understanding of the pre-approval, approval, and post-approval processes. This session also provides a built- in hour of ethics credit. Topics of discussion will include:

Topics of discussion will include:

• Examining the FDA’s structure, authority, and organization
• The 3 major FDA centers and their roles
  • – CDER (Drug)
  • – CBER (Biologics)
  • – CDRH (Device)
• Reviewing major FDA regulations and applicable laws
• Defining drugs, biologics, and devices
• Understanding the role of labeling with respect to these definitions
• Differentiating types of drug applications (INDs, NDAs, and ANDAs)
• Exploring the clinical trials process
• Investigating biological products and biosimilars
• Evaluating post-market dilemmas and enforcement
• Understanding recalls and withdrawals
• Examining recent developments at FDA
• FDA’s policies and procedures
• Administrative Procedures Act
• Working with the FDA through formal and informal dispute resolution mechanisms
• Analyzing ethical dilemmas that may occur throughout various stages of interaction with the FDA, including the approval process related to the disclosure of adverse information