Navigating the Approval Process for Drugs and Biologics

March 22, 2023 9:15am

Kinsey S. Reagan
Kleinfeld, Kaplan and Becker, LLP (Washington, DC)

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, breakthrough 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 small molecules
  • Examining standards for approvals
  • REMS

OTC Products

  • Understanding the concept of “OTC” (OTC-ness)
  • Examining the OTC Review and monographs
    • Differences between approved and monographed OTC drug products
  • Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements