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