FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Enforcement

Member, Joanne Hawana will be co-presenting at the American Conference FDA Boot Camp on the workshop titled, "FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Enforcement" with Seth Mailhot, Partner at Husch Blackwell LLP. 

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:

• Examining the FDA’s structure, authority, and organization, including the 3 major FDA centers and their roles: CDER (Drug); CBER (Biologics); CDRH (Device)
• Reviewing major FDA regulations, policies, procedures, and applicable laws
  • Examining recent developments at FDA
• Defining drugs, biologics, and devices and understanding the role of labeling with respect to these definitions
• Differentiating types of drug applications (INDs, NDAs, and ANDAs)
• Exploring the clinical trials process
• Understanding post-market dilemmas, recalls and withdrawals
• Identifying the enforcement and investigations players and their positions
• Unpacking FDA compliance and enforcement mechanisms
  • Inspections (for cause versus routine inspections) and communications with FDA during inspections
  • Form FDA 483 observations, Untitled and warning Letters, and establishment inspection reports (EIRs)
• Understanding potential punishments, including civil seizure, injunction, civil monetary penalties, and criminal prosecutions
• 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