Regulatory Affairs Certification (RAC) Practice Exam

Your company recently submitted a Biologics License Application (BLA) to CDER and received a request to develop a Medication Guide. This request may have resulted from any of the following EXCEPT:

1. The product is one that has been demonstrated through adequate and well-controlled trials to be less effective than alternative therapies.

2. The product carries significant risks that require patient counseling.

3. The product is intended for a specific patient population with unique risks.

4. The product requires monitoring for safety in certain populations.

The correct answer is: The product is one that has been demonstrated through adequate and well-controlled trials to be less effective than alternative therapies.

The request to develop a Medication Guide typically arises from concerns regarding patient safety, effective communication of risk information, and the need to ensure that specific patient populations are adequately informed. Medication Guides are required when a product is considered to have significant risks associated with its use that necessitate patient counseling (as seen in the second choice), is intended for specific populations with unique risks (as indicated in the third choice), or requires monitoring for safety in particular groups (as mentioned in the fourth choice). The first option relates to the notion that a product being less effective than alternatives does not inherently create the same level of safety concern that would necessitate the provision of a Medication Guide. The effectiveness of a treatment does not directly correlate with the requirement for additional patient information or monitoring; hence, simply demonstrating that a product is less effective does not justify the need for a Medication Guide. Consequently, this is the correct choice as it does not align with the typical reasons for a Medication Guide request.