US FDA To Screen Rx Drug Launch Promos Prior To Initiating Review

Office of Prescription Drug Promotion is adding a five-day screening period to its review of core prescription drug launch materials to determine if they are actually core promotions with all necessary information. Companies can decide whether to resubmit materials deemed non-core or have FDA go forward with a non-core launch review.

Review document
FDA adds screening process to its review of Rx drug launch promotions • Source: Shutterstock

In an effort to provide more timely review of core prescription drug launch materials, the US Food and Drug Administration is adding a five-day screening period to the review process to make sure companies have submitted the appropriate information.

Susannah O’Donnell, review team leader in the Office of Prescription Drug Promotion, explained in a webinar that during the screening period, the agency will confirm that a submission is complete and consists of core

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