BRF Interview Guide: External Stakeholders OMB Control Number 0910-0360
BRF Interview Questions: External Stakeholders
First, do you have any general comments about BRFs that you’ve seen that you would like to offer before I ask specific questions?
Information on FDA decisions – How important is it to you to understand FDA’s regulatory decisions on new drugs and biologics?
Over the past few years, how often have you sought information about FDA’s regulatory decisions on specific new drugs and biologics?
[If they do seek out information] Where have you typically looked to find this information?
[If they do seek out information] How have you used the information you have found?
Key Takeaways – Thinking about the BRFs that you have read, what were the biggest “takeaways” for you?
Did anything in the BRFs surprise you?
After reading the BRFs, did you have any further questions about how FDA came to its decisions?
Clarity – How clearly is the content presented?
“Clear” is defined as key points are stated explicitly, sequenced logically, and chunked logically; you can follow the logic underlying the regulatory decision.
On a scale of 1 to 4, where 1 is not at all clear and 4 is very clear, how would you rate the clarity of the BRFs you have seen?
In what ways is the content presented clearly?
In what ways can the clarity be improved?
For example:
To what extent are key points stated explicitly?
To what extent is content related to each key point chunked together?
To what extent are key points presented in a logical sequence?
To what extent can you follow the logic underlying the regulatory recommendation?
Understandability – How understandable are the BRFs that you have read?
“Understandable” is defined as simplest words and sentence structures are used, and terms are used precisely.
On a scale of 1 to 4, where 1 is not at all understandable and 4 is very understandable, how would you rate the understandability of the content presented in the BRFs you have seen?
In what ways is the content understandable?
In what ways can the understandability be improved?
Usefulness – To what extent are the BRFs useful to you?
On a scale of 1 to 4, where 1 is not at all useful and 4 is very useful, how would you rate the usefulness of BRFs for your purposes?
How have you used or how do you plan to use BRFs?
How useful is the BRF for these purposes?
How can the usefulness of BRFs be improved?
How else would you like to use the BRF [if it contained the needed information]?
How would the BRF need to be adjusted to accommodate these uses?
Is there anything else that you would like to add about the BRFs you have seen?
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Valerie Overton |
| File Modified | 0000-00-00 |
| File Created | 2021-01-27 |