Navigating the Approval Process for Drugs and Biologics

March 13, 2024 9:15am

Jason F. Conaty
Counsel, Global Regulatory
Hogan Lovells US LLP

Innovator Products: New Drug Applications and Biologic License Applications The Drug Review Process

  • Reviewing the fundamentals of applications; from submission, through filing and beyond
  • Making sense of PDUFA Goals, fast track, break through status, and other process enhancements
  • Use of administrative appeals

Rx Drugs (Small Molecules)

  • Understanding the difference between “new drugs” and other drugs
  • Examining the research, development, and approval process for new drugs
  • Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)

Biological Products (Large Molecules)

  • What are biological products in relation to traditional drugs?
  • Deciphering the biologics license application (BLA)
  • How do the research, development, and approval process for biological products differ from the process for new drugs?
  • Exploring key similarities and differences between the drug and biological product schemes

NDAs and BLAs

  • Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs
  • Identifying applications for fixed-dose combination drugs
  • Distinguishing complex molecules regulated through NDAs from from small molecules
  • Examining standards for approvals
  • REMS
  • Gaining comprehensive insight into the multitude of sponsor meetings, their timing, purposes, and the overarching procedural aspects