Question

After which phase of clinical trials do pharmaceutical companies submit a New Drug Application (NDA) to the regulatory authority?

• A. Phase I
• B. Phase II
• C. Phase III
• D. Phase IV

Hint:

Remember: NDA submission follows successful Phase III trials, while Phase IV studies are post-marketing studies conducted after drug approval.

Answer 1

The Correct Option is C

A New Drug Application (NDA) is submitted to the regulatory authority (such as the US FDA or CDSCO in India) after the successful completion of Phase III clinical trials. The NDA is a formal request to approve a new pharmaceutical for marketing and includes comprehensive data on: - Preclinical (animal) studies
- Chemistry, Manufacturing, and Controls (CMC)
- Pharmacokinetics and pharmacodynamics
- Safety and efficacy data from Phase I to Phase III trials
Let’s review the phases briefly: - Phase I: Assesses safety, dosage, and pharmacokinetics in a small group of healthy volunteers.
- Phase II: Evaluates efficacy and side effects in patients with the disease/condition.
- Phase III: Confirms therapeutic effect in a larger patient population and compares with standard treatments.
- Phase IV: Conducted after NDA approval for post-marketing surveillance and long-term side effects.
Thus, the NDA is submitted after Phase III but before Phase IV begins.