Tag: postmarketing submissions

postmarketing submissions

FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

Jan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency is “whether the firm or anyone acting on its behalf is influencing or controlling the product promotional activity or communication in whole or part,” according to a recent FDA Draft Guidance, “Fulfilling Regulatory Requirements for […]

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