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Future clinical trials specifically designed to evaluate this combination will be essential in determining its safety profile and optimal use

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The FDA warning letter, while not necessarily reflecting product quality, signals regulatory scrutiny that some researchers factor into vendor selection

Of those letters, 94 were based on an on-site inspection of the company, 27 were the result of records requests sent under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), six stemmed from testing product samples, and the remainder were generally based on review of product labels, registration materials, and/or websites

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