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BAMR25 Web 1219Schedule of Modified Risk Tobacco Products 25% Exposure Modification OrderLegal Name (First 35 Characters) (USE CAPITAL LETTERS FOR YOUR NAME AND ADDRESS)FOR Use OnlySchedule Beginning
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FDA grants the first-ever modified by evaluating the safety and efficacy of the modification.
Any organization or individual seeking to make a modification to a FDA-approved product.
The FDA provides guidelines and forms for submitting a request for a modified approval.
The purpose is to ensure that any modifications made to FDA-approved products meet safety and efficacy standards.
Information on the modification, safety data, efficacy data, and any potential risks.
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