Q1. Currently, the FDA can allow medical countermeasures (e.g. therapies for anthrax) to be administered to humans after animal model testing and evaluation alone. What are your thoughts on this policy? Should all therapies be tested first in humans before being approved? Should investigational products whose safety and effectiveness have been demonstrated in preclinical studies only (e.g. no human study have been conducted yet) be given to patients in dire circumstances?
Q2. Please discuss nonclinical or preclinical studies that are conducted to support the evaluation of investigational medicinal products in humans. Elaborate on the importance of each of the studies in the development of medicinal products for human use.
Q3. Discuss the importance of clinical trial in the development of medicinal products for human use. In your opinion, is there ever a set of circumstances that would warrant the administration of therapies to people/patients without prior approval from the Food and Drug Administration?
Q4. Discuss the importance of clinical trial in the development of medicinal products for human use. In your opinion, is there ever a set of circumstances that would warrant the administration of therapies to people/patients without prior approval from the Food and Drug Administration?