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DTC clock ticking

Executive Summary

Drug sponsors must notify FDA by Nov. 26 if they intend to submit DTC television ads to the agency for pre-broadcast review in fiscal 2008. Such a notification constitutes a legally binding commitment to pay a review fee, which will be calculated based on the number of ads to be reviewed (1"The Pink Sheet" Oct. 1, 2007, p. 4). The DTC user fee program, authorized by the FDA Amendments Act, will fund about 27 additional staff, enabling more rapid ad review. Guidance is forthcoming on contents, format and procedures for submitting DTC packages for review, the Oct. 25 Federal Register states...
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