1. True or False:

FDA's BIMO program is a comprehensive, agency-wide program of on-site inspections and reviews designed to monitor all aspects of FDA-regulated promotion and advertising.

Reason:

1. True or False:

The requirements of the Pediatric Research Equity Act (PREA) only apply to Drug products, and cannot be deferred or waived.

Reason:

1. True or False:

The European Union (EU) Directive uses the same definition for "investigational new drug" (21 CFR 312.2(b)) and "investigational device" (21 CFR 812.3(g)) as FDA.

Reason:

1. True or False:

FDA has approved several biosimilars, but has not deemed any of them as interchangeable.

Reason:

1. True or False:

A companion diagnostic is always regulated as a combination product

Reason:

1. True or False:

For approved NDAs, under 21 CFR 314, FDA also requires Post Marketing Reporting of Adverse Drug Experiences and other Post Marketing Reports from any uses outside of the United States.

Reason:

1. True or False:

FDA will only authorize a marketing claim if it is the result of a pre-specified endpoint in the study protocol.

Reason: