KKB Partner KS Reagan to Present on Navigating the Approval Process for Drugs and Biologics at ACI’s 39th “FDA Boot Camp”

KKB Partner KS Reagan will be presenting at the American Conference Institute’s 39th Annual “FDA Boot Camp,” September 14-15, 2022.  The conference provides training in core FDA regulatory concepts for life sciences attorneys, business executives, and policy analysists.  KS’s presentation will cover how companies can navigate the approval process for drugs and biologics, including:

  • The fundamentals of the application process from submission through appeals;
  • The research, development, and approval process for new drugs;
  • Dissecting the investigational new drug application (IND) vs. the new drug application (NDA);
  • Understanding the biologics license application (BLA);
  • Exploring key similarities and differences between the drug and biological product regulatory schemes; and
  • Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs.