On December 6, Axinn partner Chad Landmon conducted a webinar entitled, "Expediting the Generic Drug Approval Process: FDA's New Initiatives on Drug Competition." In this 90-minute session, Chad methodically laid out various FDA policies, how they have been implemented, how to engage with them and how to identify possible issues. Topics of discussion included:

• The new pathways to expedite approval of generic drug applications, including 180-day exclusivity
• Best practices to obtain exclusivity and the top dont's for losing exclusivity
• Recent FDA policy statements and guidance on generic drugs and their impact on regulatory and quality professionals
• Substantive changes to REMS standards that impact ANDAs
• FDA's other policy initiatives: prioritizing generic drug review; spur generic approvals to increase competition and lower cost, while maintaining quality
• How the real cost saving benefit provided by generics doesn't come into full effect until there are multiple generic versions available