During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

• A.Request that doctors stop using the product for the off-label indication.
• B.Contact the marketing department to recall the product.
• C.Communicate with the sales department to stop using the promotional materials.
• D.Allow doctors to use the product for the off-label indication.

Comment: *

Name: *

Email: *

Verification: *

Which of the following situations does NOT require rapid communication to regulatory authorities?

• A.A clinically important increase in the rate of occurrence of an "expected." but serious
  ADR
• B.A major safety finding from a newly completed animal carcinogenicity study
• C.A lack of efficacy with a medicinal product used in treating a life-threatening disease
• D.A statistically significant increase in the number of deaths in an animal dose finding study

Comment: *

Name: *

Email: *

Verification: *

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?

• A.Property
• B.Justification
• C.Formulation
• D.Specification

Comment: *

Name: *

Email: *

Verification: *

Why is it necessary to run supplemental safety pharmacology studies?

• A.To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
• B.To substitute the utilization of GLP
• C.To provide adverse reaction reports and the results of the statistical data to the regulatory authority
• D.To comply with regulatory authority requirements related to clinical studies

Comment: *

Name: *

Email: *

Verification: *

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

• A.Adverse event caused by patient conditions
• B.Deficiency of a device found by the user prior to patient use
• C.Malfunction occurring before the end of service life of the medical device
• D.Malfunction protection operated correctly

Comment: *

Name: *

Email: *

Verification: *