Question

Which of the following represents the FDA requirements for initiation of phase I research studies?

1) Submission of an Investigational New Drug (IND) application
2) Approval of the IND application by the FDA
3) Obtaining informed consent from study participants
4) Conducting preclinical studies to assess safety and efficacy

Answer 1

The FDA requirements for initiation of phase I research studies include submission of an IND application, approval of the IND application by the FDA, obtaining informed consent from study participants, and conducting preclinical studies to assess safety and efficacy.

Step-by-step explanation:

The FDA requirements for initiation of phase I research studies include:

1. Submission of an Investigational New Drug (IND) application
2. Approval of the IND application by the FDA
3. Obtaining informed consent from study participants
4. Conducting preclinical studies to assess safety and efficacy

These requirements ensure that the drug being studied is safe and effective before moving on to further development phases.