THE PRE-APPROVAL AND APPROVAL PROCESS
Navigating the Approval Process for Drugs and Biologics

Kinsey S. Reagan
Partner
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