Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics



Date & Time

Start Date: 10/07/2021
Start Time: 1:00 pm
End Time: 5:00 pm EDT


Aaron Lukas will be presenting at the Hatch-Waxman and BPCIA Essentials program. This is a three week program on IP basics and regulatory fundamentals relative to small molecules and biologics for brand names, generics, and biopharmas. Aaron will be discussing the following: 

Rx Drugs (new drugs)

  • Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc.
  • NDA (New Drug Application): definition, contents, and regulatory overview
  • INDA (Investigational New Drug Application) aka “IND”
    • How does it differ from an NDA?
  • Accelerated approvals
  • Defining eligibility criteria for accelerated approval and priority reviews
  • What portions of approval submissions might FDA release and when?
  • Using advisory committees in the approval process


  • How does the approval process for a biologic differ from that of a drug?
  • BLA (Biological Licensing Application): application and filing
    • How does a biologic differ from a drug?
    • Which products require BLAs instead of NDAs?
  • Why is it a “license” rather than an “approved application”?



Aaron Lukas, Ph.D.

Co-Chair, Hatch-Waxman & Biologics Litigation


(202) 912-4823

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