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FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...

Carlo Felizardo, Jane Kalinina, Meredith Manning, Susan S. Lee.


FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

USA - April 18 2018 In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies...

Heidi Gertner, Robert Church.