In this session, panelists will demystify the 505(q) Citizens Petition process, equipping Hatch-Waxman litigators with the knowledge and tools to effectively utilize this valuable regulatory tool.

Topics of discussion will include:

• Leveraging 505(q) Citizens Petitions as a strategic tool in Hatch-Waxman litigation
• Examining how 505(q) petitions have impacted FDA drug approvals
• Understanding of the petition process, including the nuances of drafting, submission, and navigating potential challenges
• Understanding the criteria FDA considers when evaluating a petition
• How does FDA determine the petition’s primary purpose was to delay?
• Analyzing market exclusivities to be addressed in the petition
• Detailing what should be included and what the process entails
• Taking stock of recent decisions involving Citizens Petitions
• Best practices for the reconsideration process and litigation