Which regulatory concept describes the process that starts with an IND submission and ends with an NDA submission?

Which regulatory concept describes the process that starts with an IND submission and ends with an NDA submission?

• A. IND submission only
• B. IND versus NDA
• C. NDA submission only
• D. Phase I/II/III progression

Answer: (B)

The main idea here is the regulatory pathway a drug follows in the U.S. from first-in-human testing to marketing approval. It starts with an IND that lets a sponsor begin clinical studies, and it culminates in an NDA that seeks authorization to market the product. Between these two milestones, developers conduct Phase I, II, and III trials, gather safety and efficacy data, and assemble manufacturing information and labeling. Describing the process as the relationship or flow from IND to NDA captures the full regulatory journey, not just a single submission. The other options don’t fit because one focuses only on starting human studies, another on submitting only the NDA, and the last on trial phases rather than the regulatory transition.

The main idea here is the regulatory pathway a drug follows in the U.S. from first-in-human testing to marketing approval. It starts with an IND that lets a sponsor begin clinical studies, and it culminates in an NDA that seeks authorization to market the product. Between these two milestones, developers conduct Phase I, II, and III trials, gather safety and efficacy data, and assemble manufacturing information and labeling. Describing the process as the relationship or flow from IND to NDA captures the full regulatory journey, not just a single submission. The other options don’t fit because one focuses only on starting human studies, another on submitting only the NDA, and the last on trial phases rather than the regulatory transition.