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



Date & Time

Start Date: 10/13/2022
Start Time: 1:00 pm
End Time: 2:15 pm EDT


Keri Schaubert will present at the 2nd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA Conference. Keri will join a panel discussing identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc. 

Rx Drugs (new drugs)

  • 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”?


Share on LinkedIn


Keri L. Schaubert, Ph.D.



(212) 883-2258

Related Practices