BIOLOGICS "COMING SOON" ADS SHOULD BE PRECLEARED
BIOLOGICS "COMING SOON" ADS SHOULD BE PRECLEARED by FDA's Advertising & Promotional Labeling Staff as part of the introductory package of advertising materials, Center for Biologics Evaluation & Research APLS Director William Purvis explained at a recent Food & Drug Law Institute meeting. A prepared outline of Purvis' speech states that "coming soon" ads are "just as important as the post-approval campaign, [and have] the potential to convey improper or misleading suggestions about the product before licensure." Therefore, the outline states, "APLS will recommend revising the procedural guide to ensure that this type of advertising and promotion continue to be submitted for review."
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