Regulatory Open Forum

This inquiry came from  a colleague and we had a difficult time arriving at a straightforward answer. There various approaches across companies and no clear guidance from OPDP. What regulations or guidance exist to dictate where to place the indication within an email of a boxed warning product? Is it customary to have it before any claims are made about the product or at least in close proximity? Should the boxed warning appear close to the indication?

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Diana Mason
North Chesterfield VA
United States
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Dear Diana,

Unfortunately your post did not get any comments.
I am very curious how did you handle this situation yourself
From the websites on Rx with a Boxed Warning, i see that all the information about Boxed Warning is presented right after Prescribing Information. For instance, if the website mentions PI somewhere as a link it follows by a Boxed Warning. Like, Prescribing Info & BOXED WARNING.


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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
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Original Message:
Sent: 12-Sep-2018 22:05
From: Diana Mason
Subject: US Advertising and Promotion

This inquiry came from  a colleague and we had a difficult time arriving at a straightforward answer. There various approaches across companies and no clear guidance from OPDP. What regulations or guidance exist to dictate where to place the indication within an email of a boxed warning product? Is it customary to have it before any claims are made about the product or at least in close proximity? Should the boxed warning appear close to the indication?

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Diana Mason
North Chesterfield VA
United States
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What I have seen with companies is that the indication and BW goes above the signature line of any email and some companies have a please see statement at the beginning/further up in the email.

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Alicia Whittlesey
Counsel and Director of Compliance Services at Porzio Bromberg & Newman P.C.
Westborough MA
United States
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Original Message:
Sent: 12-Sep-2018 22:05
From: Diana Mason
Subject: US Advertising and Promotion

This inquiry came from  a colleague and we had a difficult time arriving at a straightforward answer. There various approaches across companies and no clear guidance from OPDP. What regulations or guidance exist to dictate where to place the indication within an email of a boxed warning product? Is it customary to have it before any claims are made about the product or at least in close proximity? Should the boxed warning appear close to the indication?

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Diana Mason
North Chesterfield VA
United States
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