6 Questions
What type of study is a clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application?
Phase 3
In which phase of clinical trials are the data usually considered for marketing application?
Phase 3
Which phase of clinical trial involves testing the drug on a larger patient population to determine its efficacy and safety?
Phase 3
What should the sponsor of a potential IND do to obtain a notice of exemption of IND requirements from the FDA for a particular clinical study?
Submit a notice to FDA that the study is IND exempt and then start the study
Which document submission process is required to obtain a notice of exemption of IND requirements from the FDA?
Submitting a notice to FDA that the study is IND exempt
What is the initial step for a sponsor seeking exemption of IND requirements from the FDA for a clinical study?
Submitting a notice to FDA that the study is IND exempt
Study Notes
Clinical Trials and FDA Regulations
- A clinical trial powered to show the efficacy of a drug in a specific disease population is typically conducted for a marketing application.
- Data from Phase III clinical trials are usually considered for marketing application.
- Phase III clinical trials involve testing the drug on a larger patient population to determine its efficacy and safety.
Obtaining Exemption of IND Requirements from the FDA
- To obtain a notice of exemption of IND requirements from the FDA, the sponsor of a potential IND should submit a request to the FDA.
- The document submission process required to obtain a notice of exemption of IND requirements from the FDA is a written request.
- The initial step for a sponsor seeking exemption of IND requirements from the FDA for a clinical study is to submit a written request to the FDA.
Test your knowledge of clinical trial phases by identifying the phase of a trial designed to demonstrate the efficacy of a drug for marketing application.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
