Hey @kshulist

The disclaimer is generally requested when any non-clinical features/characteristics extend to/may suggest a clinical benefit. This would include experience claims such as the example provided (# of patients worldwide). The disclaimer is presented to be clear that the number of patients worldwide should not be extrapolated to significance of the efficacy or safety profile of the medication. As a courtesy, the copy “prescribed worldwide” would have to be supported with validated global data which tracked prescriptions to validated new patients.

@jennifer-carroll Thank you!

@jennifer-carroll Thank you!

Hey @matt-s17

If the warning and precaution is clearly limited to one indication which is not presented in the piece, then no, it would not be required in a piece which did not have mention of that indication.

Hey @gmc

Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.

It can appear anywhere in the piece as long as it appears at least once.

Hello @jesse-gibbings

If you have entered into a contractual agreement with the MAH to co-promote the products, you should ensure that all advertising meets the regulatory standards for both your products and the MAH products. See Code section 1.4.c.

Good morning @Username, sorry for missing this question – let's see if we can still help you with this

It's important to not confuse the directions for patient pieces and HCP detail aids. The situation you are describing in paragraph two appears to be mixing the directions for patient and HCP. Patient material should be non-promotional information. In the situation where there is a combination of multiple NOC and/or NOC/c’s which cross the same therapeutic category, the copy should be clearly limited to the NOC population. If the copy is broad and could encompass the NOC/c to some degree, the NOC/c would be required to be presented in the piece.

For the question in paragraph three, “at first mention of the therapeutic category” refers to pieces where there may be NOC and NOC/c in different therapeutic categories. For example NOC for RA and NOC/c for UC. If the piece doesn’t mention UC until page 3, the NOC/c disclosure is not required until that page as that is first mention.

In a situation where you have one NOC and one NOC/c within the same therapeutic area and presented together upfront, the first presented option within the document Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc should be followed. For example, the complete boxed NOC/c copy from the cover should be presented.