Submit Launch Campaign

Launch campaigns are introductory promotional campaigns for a new drug or for a new indication or dosage for an already marketed drug. The campaigns usually contain a variety of promotional pieces, such as detail aids, monographs, advertisements, and press kits.

DDMAC advises the pharmaceutical industry on proposed advertising and promotional labeling, as specified in 21 CFR 202.1(j)(4). DDMAC has requested in guidance to industry that launch campaigns be submitted voluntarily to DDMAC for comment before dissemination. Launch campaigns are DDMAC's highest review priority, because these campaigns create the initial and often lasting impression to prescribers regarding the product's safety and efficacy. Reviewers generally respond to applicants within 2 to 3 weeks after the product is cleared for marketing or after the labeling issues have been negotiated.