Interviews with Applicants and Other External Stakeholders Regarding Use of Patient Experience Data in Regulatory Decision Making (CDER)

Use of Patient Experience Data in Regulatory Decision Making: External Stakeholders Interview Script October 23, 2020

FDA Use of Patient Experience Data in Regulatory Decision Making

External Stakeholders Interview Script

October 23, 2020

Paperwork Reduction Act Statement: Public reporting burden for this collection of information is estimated to average 60 to 90 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Your participation/nonparticipation is completely voluntary, and your responses will not have an effect on your eligibility for receipt of any FDA services. An agency may not conduct or sponsor, and a person is not required to respond to a collection unless it displays a currently valid OMB control number. The control number for this project is 0910-0360. Send comments regarding this burden estimate or any other suggestions for reducing this burden to: Food and Drug Administration, Office of Operations, Food and Drug Administration, 3WFN, 11601 Landsdown St., North Bethesda, MD 20852.

The study we are conducting is on behalf of the U.S. Food and Drug Administration.

FDA Use of Patient Experience Data in Regulatory Decision Making and Communication About this Use

1. How easily were you able to find information about how FDA uses patient experience data in its reviews of drug applications?

Probes: How easily were you able to find the documents? How easily were you able to locate information within the documents?

2. In the documents you read, how would you characterize the patient experience data that FDA considered in its drug reviews?

Probes: How adequate were the types of patient experience data that FDA considered? What is your impression of the quality and completeness of the data? What types of data would you like industry to provide to FDA in their drug applications? What other sources of patient experience data would you like FDA to consider?

3. In the documents you read, to what extent did FDA provide the information you want about how the Agency uses patient experience data in its drug reviews?

Probes: What types of information do you want to see? Of the information you saw, what was helpful? What was not helpful, insufficient, or missing?

4. How would you rate the clarity of the information about FDA’s use of patient experience data?

Probes: How understandable was the information? How complete? How logically was it presented?

5. What good practices do you observe in how FDA uses patient experience data in its drug reviews? In communicating how it uses these data in deciding whether to approve drug applications?

6. What suggestions for improvement can you offer?

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