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  • World Menopause Day

    World Menopause Day

    Bone Health
    18 October 2021

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  • AMS Congress

    AMS Congress

    26-28 November 2021
    Adelaide, South Australia

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  • AMS Webinar

    AMS Webinar

    What’s new - The use of testosterone in women
    Available for viewing now

    Read more

  • Early Menopause and POI

    Early Menopause and POI

    Management resources for women
    and their health professionals

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  • Health Information

    Health Information

    Find an AMS Doctor, news,
    self-assessment tools and videos

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  • Health Professionals

    Health Professionals

    Menopause management resources,
    news, position statements

    Read more

  • Menopause management

    Menopause management

    AMS supporting women through
    midlife health and the menopause

    Read more

  • AMS eLearning

    AMS eLearning

    A benefit for AMS Members
    webinars, case studies
    with CPD points

    Read more

  • Menopause Videos

    Menopause Videos

    Explaining issues women
    worry most about

    Read more

AMS Congress

AMS 2021 Congress

Join us in Adelaide from 26-28 Nov for the 24th Annual AMS Congress. Share experiences and knowledge gained as we have all adapted in our approaches to Midlife and Menopause issues across the pandemic. Go to Congress page.

AMS Webinar available to view

AMS Webinar What's new The use of testosterone in women

AMS is pleased to bring you this webinar on the use of testosterone therapy in women. For GPs, endocrinologists, gynaecologists, pharmacists and other healthcare professionals. 
Learn more here.

Members

AMS Members

If your work focuses on menopause and issues related to women's midlife health, become a Member of the AMS. Access information and resources which will inspire and guide improvements for your practice. Members only information.

AMS eLearning

AMS eLearning Website

AMS eLearning is free to register with low cost courses (free for AMS members). Access webinars, case studies, quizzes and other learning that attract 2020-22 CPD points.
Access here.

Health Professionals

Health professionals

Health Professionals includes AMS Congress updates, information sheets, menopause management resources, news, position statements, a selection of studies published, NAMS videos and more... See Health Professionals.

What's New | Features

What's New | Features

View the latest articles available on the AMS website. See What's New here.

View articles, resources, position statement or events of particular interest. See Features here.

The FDA Office of Women's Health report

23 May 2016

The US Food and Drug Administration Office of Women’s Health (FDA OWH) has just published an update on its activities during the recent years [1]. This report opens a window on current FDA fields of interest in women's health. Evidently, the role of any regulatory agency is, first, to optimize medical product development and to evaluate product safety and efficacy. OWH also invests in research projects and dictates the exact trial design, and the type of data to be collected and analyzed. Among the fields on which the OWH has focused were early detection of breast cancer, lung cancer in women, vertebroplasty for osteoporotic fracture, HIV, and pregnancy. In the past, clinical trials did not include a desired percentage of women. This was corrected at the beginning of the millennium, as the FDA imposed new rules to allow adequate representation of demographic groups by sex, age, and race/ethnicity in clinical trials, so that evidence-based clinical decisions can be made that are applicable to all patients who will use the medical product following approval.

As for specific menopause issues, dietary supplementations are discussed. Dietary supplements are not subject to FDA approval before being marketed, but the FDA may proceed with regulatory action if it can be shown that the supplement is unsafe. One reason that women take supplements is to relieve menopausal symptoms. It is estimated that up to 79% of women aged 40–60 use botanical dietary supplements [2]. Widespread use enhances concerns about the safety of these supplements. For example, one of the supplements investigated by an FDA OWH-funded study, black cohosh, had been reviewed by the United States Pharmacopeia (USP) and National Institutes of Health (NIH) Office of Dietary Supplements, due to several reports of hepatotoxicity [3]. The FDA investigator compiled a list of lead chemicals and structural motifs that commonly contributed to predictions of adverse events, which may be of use for future experimental designs.

 

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