Chazzle wrote: Can you verify whether the FDA requ
Post# of 155043
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Posted On: 09/28/2022 2:11:42 AM
Re: chazzledazzle #128903
Chazzle wrote:
Chazzle, seems like you have decided the FDA didn't ask for the banner, no matter how many people inform you they did. The FDA didn't ask for "a banner" but it certainly asked for something like it. The FDA warning letter is not hard to find: https://www.fda.gov/inspections-compliance-en...7-02112022 . Here's some really boring reading for you:
Quote:
Can you verify whether the FDA required us to place the banner? Truthfully I can’t recall. Or did we just do it mea culpa style?
Chazzle, seems like you have decided the FDA didn't ask for the banner, no matter how many people inform you they did. The FDA didn't ask for "a banner" but it certainly asked for something like it. The FDA warning letter is not hard to find: https://www.fda.gov/inspections-compliance-en...7-02112022 . Here's some really boring reading for you:
Quote:
Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter . OPDP recommends that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand leronlimab; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.
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