The tropical disease priority review user fee rate is assessed and determined on an annual basis, and is “based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year.” According to the Agency, the fee is used to cover the “incremental costs for FDA to do a priority review on a product that would otherwise get a standard review,” and allows it to have the necessary resources that are required to conduct a priority review.
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FDA Issues Final Rule to Delay Implementing Parts of ‘Intended Use’ Regulation
On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the...