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The fees will commence in Fiscal Year 2021 and will be based on the number of active OTC monograph drugs that are sold to the general public.<br><br>The CARES Act also includes many changes to improve OTC monographs for drugs. These include the possibility of having closed meetings with the FDA regarding OTC monographs and an exclusive period for some OTC monoograph drugs. These measures are designed to assist the FDA keep abreast of the most recent safety and efficacy data.<br><br>FDA Approval by FDA<br><br>The FDA's Center for Drug Evaluation and Research or CDER reviews new drugs prior to allowing them to be sold. It ensures that these drugs are safe to use and that their benefits outweigh their risks. This allows doctors and patients to make informed decisions on the best way to use these drugs.<br><br>FDA approval can be obtained in a variety of ways. Evidence from science is used to support the FDA approval process. 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