Question

The FDA regulations apply to research subject through to supervision of the FDA itself, because the research involves:

drugs

devices

data to be submitted

A & C only

All of the above

Answer 1

Correct option is D all of the above.

FDA : federal food ,drug and , cosmetic act. Was amended.

Intended to diagnose , cure , mitigate ,treat ot prevent diseases

All defination are keyed to intended to or for"

Change in intended use can render a product that might look like one regulated commodity eg (a food) into other( eg . Adrug).

As FDA RESEARCH include the

1) discoveries : basic research in laboratory,

Identify promising drug / biologic

2) preclinical studies: laboratory and animal testing , answer basic safet questions

3)Clinical studies : testing in increasing in the number of human,establish safety and efficacy.

4) FDA review thorough examination of all data submitted , decide to approve or not

5)post approval research and monitoring: ongoing reporting and monitoring, research to answer questions, ot expand therapeutic value.

Hence FDA include all options.

Please please upvote if you find it satisfactory comment if any doubt.

This includes the food , biological product which may include. Drugs, device to diagnose Only and they have to submit the research data. And evaluation of research