Use and effect of <i>Ephedra</i> weight loss products – a pilot cohort study

Warber, SL; Wunder, Jenna; Schiller, Amy; Sandretto, Annette; Uhley,; Bolling, Steven F.

doi:10.1111/j.2042-7166.2003.tb04090.x

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Postmarketing Studies For Medical Products1

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2016

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“…75 Because of the prevalence of use by women and because there is limited efficacy and safety information on supplements in comparison to drugs, FDA OWH has funded research on dietary supplements over the years, including past research on ephedra containing weight loss supplements. 76 …”

Section: Postmarketing Studies For Medical Productsmentioning

confidence: 99%

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Obias-Manno

Scott

Kaczmarczyk

et al. 2016

Journal of Women's Health

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The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

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Section: Postmarketing Studies For Medical Productsmentioning

confidence: 99%