Does anyone have experience with Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use, Form FDA2253? I have a price catalog I need to submit into FDA, but uncertain if it is required to reveal our prices. I've been told no, but I do not see any regulation stating this either way.
In Annual Reports you are permitted to omit the prices, but for consumer promotional material you are required to reveal prices. My promotional material is not for the use of a consumer, but rather for professional pricing. Once again does anyone have experience in this relm and possibly a guidance, regulation, or just plain old good advice on this topic?
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Raylene De La Rosa
Terumo BCT, Inc.
Lakewood CO
United States
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