Question

during the course of administration of an investigational drug, the following events occur: on day 7, subject 603 has an unexpected stroke that requires hospitalization. on day 15, subject 415 complains of nausea, vomiting, and headache relieved by aspirin. on day 21, subject 20 has brief dizzy spells upon trying to stand. an ind safety report is most likely filed by the sponsor with the fda for the observations associated with:

Answer 1

An IND Safety Report would be most likely filed by the sponsor with the FDA for the observations associated with: subject 603 only.

What is FDA?

FDA is an abbreviation for Food and Drug Administration and it can be defined as a federal agency of the government of the United States of America that is saddled with the responsibility of protecting the consumers of drugs and other edible products from hazards (poisons), as well as promoting and enhancing public health safety.

What is an IND Safety Report?

IND Safety Report is a short terminology for Investigational New Drug Safety Report and it can be defined as any findings from tests that are conducted in the laboratory on animals which suggest a significant risk for human subjects, when the drug is used.

Based on the information provided, we can reasonably infer and logically deduce that an Investigational New Drug (IND) Safety Report would be most likely filed by the sponsor with the Food and Drug Administration (FDA) for the observations associated with subject 603 only because it  suggest a higher and significant risk for human subjects.

Read more on IND Safety Report here: brainly.com/question/28084797

#SPJ1