Which of the following is the MOST desirable timing and approach for a regulatory affairs professional
who wants to provide feedback on proposed new regulations?

A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?

GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation
based on which of the following?

A company is considering the development of a medical device similar to those already available. Which
of the following should be evaluated FIRST when developing a clinical evaluation document?

Which of the following BEST describes the purpose of the ICH?