Regulatory Affairs Certification (RAC) Global Scope: RAC-GS

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

A. "Is the product profitable for the manufacturer?"

B. "Is the product better than currently available alternatives?"

C. "Has the product been approved for morand4nan 10 years?"

D. "Is the product an established gold standard?"

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. Specification

B. Formulation

C. Property

D. Justification

Which of the following statements regarding the off-label use of drugs is CORRECT?

A. Although the regulatory authority reviews and approves drugs for specific indications, theapproval does not limit the use of those drugs in clinical practice.

B. The regulatory authority does not restrict physician prescribing for off-label indications orregulate the manufacturer's promotion for such use.

C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

D. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing accessto much needed drugs and devices.