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However, that decision was based on FDAs asserted failure to take into account the applicants plans for marketing and sales access restrictions for its flavored products to reduce youth usage, a failing the court described as procedural. The court remanded the application back to FDA for the agency to consider the proposed marketing and sales access restrictions which, as the dissent argued, is likely to result in exactly the same result, based on FDAs prior findings that such restrictions are destined to be ineffective in preventing youth usage of flavored products

Data Validation & Market Feedback: Validation is the most important step in the process

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