The Nature of the Approval Process
Geoffrey M. Levitt
Associate General Counsel Regulatory, Environmental and Global Supply
- 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
- 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
- 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