A company is developing a device-drug combination product. Which of the following should be evaluated
FIRST in order to determine the applicable guidance documents?

The safety database for an anti-hypertensive drug consists of the following:
. 461 patients exposed for three months
. 343 patients exposed for six months
. 112 patients exposed for nine months
. 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

A request was received from a regulatory authority asking the company to conduct product testing in
compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the
medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

Which of the following claims would classify an apple as a drug?