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.
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.
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