4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

FDA Regulatory partner, George O’Brien will discuss “Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity” during ACI’s Hatch-Waxman and BPCIA Proficiency Series, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of Hatch-Waxman and BPCIA litigation and regulation.

The panel will discuss:

• Understanding which drug products are eligible for regulatory exclusivity
  
  • small biologics v. biologics
• The different modes and methods of regulatory exclusivity (non-patent)
  
  • NCE (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity
  • indication (new indication or use): 3 years marketing exclusivity
  • NDF (new dosage formulation)
  • ODE (orphan drug exclusivity)
  • PED (pediatric exclusivity)
• FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA
• What role does the FDA play in regulating these modes of exclusivity?
• When are each of these methods sought?
• Using trade dress as means of exclusivity

For more information and to register, please visit the event webpage.