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This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

Hello Anon,

Yes, I always include this type of sentence in FDA meeting requests.  All of my other "questions" are more statements about what we are going to do, how we are doing it, what is expected, acceptance criteria, etc., then the FDA reviewer can agree or disagree.  Then at the end, 'thank you for the review and does the Agency have any other comments or information to provide' type of question.  Depending on the type of device and type of application, the reviewer (review team) would compose 2 to 20 additional line items for consideration.  For me, it is always a final question at the end.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

I have always avoided open-ended questions. My rule has always been to ask yes/no questions. My experience is that review teams (in CDER) will add whatever comments they have on the overall development program. (I guess that is particularly true for clinical pharmacology. In general, I would say, we don't ask enough clinical pharmacology questions in later phase meetings/advice requests. However, clinpharm reviewers will often add comments or advice.)

When requesting written comments/advice, I can't remember an occasion where there were not additional comments from some discipline - whether clinical pharmacology, biostatistics, nonclinical pharmacology, etc. Do we miss out on valuable advice by not asking an open-ended question? In my experience, no. But, maybe that is a result of having developed a collaborative relationship with the review team.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

I used to avoid them because I thought that FDA would tell us what we need to know in the other responses...or I was afraid of hearing something I didn't want to know!  But now, I generally add something like "is there anything else that would facilitate the agency's review". Sometimes I will get responses about a certain analysis that should be included, certain formats of various datasets, etc. Sometimes the response is "please see above". But I've found it doesn't hurt and sometimes there is a nugget of information that is helpful to both the sponsor and FDA.

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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

This message was posted by a user wishing to remain anonymous

My opinion - avoid it. The Jan 2021 Q-Sub guidance says "A Pre-Sub should include clear, specific questions." There is nothing that says an open-ended question will result in a rejection of the Pre-Sub, but including such may lower your credibility with the reviewer, as it will look like you are ignoring the guidance. It may be better to try to be as specific as possible in order to catch "additional comments," such as writing "ABC is our current strategy for XZY; does FDA find this acceptable?" It's not very specific, but you can bet that FDA will explain their yes or no answer. We have done this successfully in the past with a 510(k) pre-sub in order to get as much of their opinion as possible to inform the V&V program. The subsequent 510(k) review was relatively quick. We also included a table that linked every piece of their Pre-sub feedback to our 510(k) decisions, and where the evidence was located.
Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

I've generally avoided that question and have kept to specific questions.

Regardless of whether or not you ask, if FDA has any additional comments, they will let you know at the end of the written feedback.

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Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
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Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

I recommend laser sharp, YES/NO -type questions...

Still feel like presubs a big waste of time... long lead times and not giving any real value / commitment from FDA.
Maybe good for very novel/innovative products.

Best regards,
Hannes

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Hannes Hyvonen
RA Manager at Icare Finland
Vantaa
Finland
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Original Message:
Sent: 10-Sep-2021 17:53
From: Hiral Dutia
Subject: Thoughts on open-ended questions in FDA meeting requests?

I've generally avoided that question and have kept to specific questions.

Regardless of whether or not you ask, if FDA has any additional comments, they will let you know at the end of the written feedback.

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Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?

I've always been advised to be as specific as possible with questions, but I've never seen it tried to ask a question like you suggest. As someone else mentioned, we've generally received additional comments from FDA anyway (though usually it's stuff we're already doing).

Note that experience may be different depending on which part of FDA you're addressing: Clinical reviewers vs. CMC, CDER vs. CBER vs. CDRH, even different review divisions

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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 04-Sep-2021 22:10
From: Anonymous Member
Subject: Thoughts on open-ended questions in FDA meeting requests?

This message was posted by a user wishing to remain anonymous

In the list of questions section in a formal FDA meeting request/briefing package, should a company include a final open-ended question to the effect of "Does the Agency have any additional comments?"? Does anyone have specific examples of when this has been beneficial vs resulted in new unwanted challenges?