Solved

Which of the Following Is True Regarding FDA Approval of Drug

Question 57

Multiple Choice
Which of the following is true regarding FDA approval of drug labels in relation to state law claims for failure to warn?

Which of the following is true regarding FDA approval of drug labels in relation to state law claims for failure to warn?


A) FDA approval of the label on a brand-name prescription drug does not preempt state failure-to-warn claims arising out of injuries caused by the drug nor does FDA approval of the label preempt state failure-to-warn claims related to approved generic drugs bearing the FDA-mandated label.
B) FDA approval of the label on a brand-name prescription drug preempts state failure-to-warn claims arising out of injuries caused by the drug, and federal law also preempts state failure-to-warn claims related to approved generic drugs as long as they bear the FDA-mandated label.
C) FDA approval of the label on a brand-name prescription drug preempts state failure-to-warn claims arising out of injuries caused by the drug, but federal law does not preempt state failure-to-warn claims related to approved generic drugs bearing the FDA-mandated label.
D) FDA approval of the label on a brand-name prescription drug does not preempt state failure-to-warn claims arising out of injuries caused by the drug, but federal law preempts state failure-to-warn claims related to approved generic drugs as long as they bear the FDA-mandated label.

Correct Answer:

verifed

Verified

Unlock this answer now
Get Access to more Verified Answers free of charge

Related Questions

Unlock this Answer For Free Now!

View this answer and more for free by performing one of the following actions

qr-code

Scan the QR code to install the App and get 2 free unlocks

upload documents

Unlock quizzes for free by uploading documents