Which sequence correctly describes the typical regulatory submission flow for a drug in the United States?

Which sequence correctly describes the typical regulatory submission flow for a drug in the United States?

• A. NDA Submission -> IND submission -> Phase II -> Phase III
• B. Phase I/II/III -> NDA Submission -> IND submission
• C. IND submission (30 day review) -> Phase I/II/III -> Clinical Start -> NDA Submission
• D. IND submission (30 day review) -> Clinical Start -> Phase I/II/III -> NDA Submission

Answer: (D)

Beginning with an IND application is required to start human clinical research. FDA reviews IND within 30 days to decide whether to allow clinical testing to proceed. If allowed, clinical development begins and proceeds through Phase I, Phase II, and Phase III to assess safety, dosing, efficacy, and risk in progressively larger populations. After completing the pivotal trials, the sponsor submits a New Drug Application for FDA review to obtain marketing approval. The sequence that matches this flow is: IND submission with a 30-day FDA review, followed by clinical start, then Phase I/II/III, and finally NDA submission. The other options mix the order (such as submitting an NDA before IND, or starting trials before IND approval, or trying to run Phase I/II/III before clinical trials have begun), which is not how regulatory processes unfold.

Beginning with an IND application is required to start human clinical research. FDA reviews IND within 30 days to decide whether to allow clinical testing to proceed. If allowed, clinical development begins and proceeds through Phase I, Phase II, and Phase III to assess safety, dosing, efficacy, and risk in progressively larger populations. After completing the pivotal trials, the sponsor submits a New Drug Application for FDA review to obtain marketing approval. The sequence that matches this flow is: IND submission with a 30-day FDA review, followed by clinical start, then Phase I/II/III, and finally NDA submission. The other options mix the order (such as submitting an NDA before IND, or starting trials before IND approval, or trying to run Phase I/II/III before clinical trials have begun), which is not how regulatory processes unfold.