Rx Drugs

• Understanding the difference between “new drugs” and other drugs
• Overview of the research, development, and approval process for new drugs
• The investigational new drug application (IND)—timing, content, and purpose
• The new drug application (NDA)—timing, content, purpose, and review process
• Accelerated approval (fast track)
• Different uses of the REMS process in new drug approvals

Biological Products

• What are biological products? What does it mean to say that they are also “drugs”?
• Which “new drugs” require BLAs instead of NDAs?
• How do the research, development, and approval process for biological products differ from the process for new drugs?
• The biologics license application (BLA) —timing, content, purpose, and review process
• Key similarities and differences between the drug and biological product schemes

OTC Products

• The concept of “OTC” (OTC-ness)
• The OTC Review—identifying covered drugs and defining a “monograph”
• OTC versus Rx
• Overview of how old and new OTC drugs come to market