FREE RAC Product Labeling and Advertising Questions and Answers

Question 1

A pharmaceutical company plans to launch a direct-to-consumer (DTC) television advertisement for a prescription drug.
According to FDA regulations (21 CFR 202.1), what is a mandatory component of this type of advertisement?

Accepted Answer

A "major statement" presented in a clear, conspicuous, and neutral manner, disclosing the major side effects and contraindications.

Answer

A statement that the product is available by prescription only.

Answer

The complete prescribing information scrolled on the screen.

Answer

Pre-approval of the advertisement's final script by the Office of Prescription Drug Promotion (OPDP).

Question 2

In the United States, regulatory authority over the advertising of drug and device products is divided between the FDA and another agency. The advertising for over-the-counter (OTC) drugs is primarily regulated by which of the following?

Accepted Answer

The Federal Trade Commission (FTC)

Answer

The Drug Enforcement Administration (DEA)

Answer

The Consumer Product Safety Commission (CPSC)

Answer

The Office of the National Coordinator for Health Information Technology (ONC)

Question 3

Which of the following activities is MOST likely to be considered prohibited "off-label promotion" by a pharmaceutical company representative?

Accepted Answer

A sales representative proactively detailing physicians on using their approved analgesic for a new type of pain not included in the Prescribing Information.

Answer

A Medical Science Liaison (MSL) providing a physician with a copy of a peer-reviewed journal article describing an unapproved use, in response to the physician's unsolicited request.

Answer

Sponsoring an independent Continuing Medical Education (CME) event where an unapproved use is discussed by the academic speaker.

Answer

Including data from a trial on an unapproved indication in an investor relations presentation.

Question 4

A medical device manufacturer is preparing labeling for a Class IIa sterile device to be marketed in the European Union. According to the Medical Device Regulation (EU 2017/745), which of the following must be affixed to the device label?

Accepted Answer

The CE mark followed by the four-digit identification number of the Notified Body.

Answer

The full address of the European Competent Authority that reviewed the technical documentation.

Answer

The UL (Underwriters Laboratories) certification symbol.

Answer

The CE mark alone, without any additional numbers.

Question 5

A pharmaceutical company becomes aware of new data confirming a causal link between its marketed drug and a previously unknown serious adverse reaction. To update the Prescribing Information to add a new warning, which is the MOST appropriate regulatory submission to the FDA?

Accepted Answer

A "Changes Being Effected" (CBE-0) supplement.

Answer

An annual report.

Answer

A New Drug Application (NDA).

Answer

A Prior Approval Supplement (PAS).

Question 6

According to U.S. FDA regulations for medical device labeling (21 CFR 801), which of the following is a required element on the label of a device intended for prescription use?

Accepted Answer

The statement "Caution: Federal law restricts this device to sale by or on the order of a physician" or the symbol "Rx Only".

Answer

The Unique Device Identifier (UDI) in plain-text format only.

Answer

The reimbursement code for the device.

Answer

The date of the last FDA inspection of the manufacturing facility.

A pharmaceutical company plans to launch a direct-to-consumer (DTC) television advertisement for a prescription drug.According to FDA regulations (21 CFR 202.1), what is a mandatory component of this type of advertisement?

A pharmaceutical company plans to launch a direct-to-consumer (DTC) television advertisement for a prescription drug.
According to FDA regulations (21 CFR 202.1), what is a mandatory component of this type of advertisement?