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Executive Summary

CBER ONLY REQUIRING PRECLEARANCE OF PROMOTIONAL MATERIALS for biologics with pending PLAs and for "newly approved" biologics, a procedural guide issued by the center's Advertising and Promotional Labeling Staff states. Previously, all ads and promotional labeling for biological products required preclearance. The guidance essentially brings CBER ad requirements in line with those extant in the Center for Drug Evaluation and Research. Current thinking, the guide notes, is that preapproval of promotional materials is required only for any biological product with a pending PLA; any licensed biological under review for a new indication; and any "newly approved" biological product. APLS staff will require preapproval submission for ad and promotional materials only for the introductory campaign -- within 120 days of a product's approval. An Aug. 9 Federal Register notice announces the availability of the guide and formally establishes the APLS staff at the Center for Biologics Evaluation and Research. The staff was formed under the CBER reorganization and has been operating since Jan. 11 within the Office of Establishment Licensing and Product Surveillance. The guide explains what procedures manufacturers and distributors must follow in submitting promotional labeling and advertising for biologics. The guide also discusses procedures the APLS staff will use in reviewing those materials. APLS staffer Toni Stifano said at the BioEast '93 conference in January that CBER was considering dropping the requirement for preclearance of all promotional material before publication or dissemination ("The Pink Sheet" Feb. 8, T&G-6). "CBER will review all advertising and promotional labeling for products that have been licensed for more than 120 days on a selected surveillance basis," the guide states. "Applicants should continue to submit to APLS final copies of all advertising and promotional materials at the time of initial publication or distribution for inclusion in their product files." The guide points out that CBER will monitor all materials to determine that they "are not false or misleading in any particular manner"; "are consistent with the current approved labeling (package insert), clinical trial data used to support licensure, any relevant information contained in the Summary Basis of Approval (SBA) and, when applicable, previously approved promotional labeling"; "present a 'fair balance' of information about the product"; and "include proper prescribing information (a minimum of a 'brief summary' for advertisements and full prescribing information for all other forms of promotional labeling)." Submit written requests for copies of the guide to the Congressional and Consumer Affairs Branch (HFM-12), FDA, 1401 Rockville Pike, Rockville, MD 20852-1448.

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