• Regulatory NewsRegulatory News

    EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines

    The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age.  The public element of the meeting means EU citizens will be invited to share their experiences with these medicines, which are approved nationally in the EU to ...
  • Regulatory NewsRegulatory News

    New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women

    The U.S. Food and Drug Administration (FDA) on Wednesday warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains. The warning comes as FDA says recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikel...
  • Regulatory NewsRegulatory News

    Legislation Calls for FDA to Ensure Expedited Drugs are Safe for Women

    New legislation introduced last week in the House of Representatives would require greater gender equity in some clinical trials overseen by the US Food and Drug Administration (FDA). The bill, the Research for All Act , was previously introduced in 2014 by Reps. Jim Cooper (D-TN) and Cynthia Loomis (R-WO), and was reintroduced in the House on 29 April 2015. Background At its core, the bill aims to address something long known by regulators and medical research offi...
  • Regulatory NewsRegulatory News

    FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities

    The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research. Background When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addre...
  • Regulatory NewsRegulatory News

    Legislators Want More Transparency About How Drugs Impact Women

    More than a month after pressing the US Food and Drug Administration (FDA) to do more to promote the participation of women and minorities in clinical trials, more than a dozen members of Congress are again pressing government officials to take action on the issue, this time focusing their efforts on clinical data transparency. Background In March 2014, a bipartisan group of female senators wrote to FDA , urging it to do more to ensure the equitable participation...
  • Female Senators Press FDA for Action on Sex-Based Differences and Clinical Trials

    A bipartisan group of female US senators is calling on the US Food and Drug Administration (FDA) to do more to ensure the equitable participation of women in clinical research. Background When the  Food and Drug Administration Safety and Innovation Act (FDASIA)  was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addressing the extent to which clinical trial participation and the inclusion of sa...
  • FDA Research Finds Women Under-Represented in Post-Approval Device Trials

    New research by regulators with the Center for Devices and Radiological Health (CDRH) has found that gender-specific data is not always assessed in postmarketing studies on the safety and efficacy of a device, potentially putting women at risk. Emphasis on Women CDRH, the US Food and Drug Administration's (FDA) medical device regulatory division, has been placing an increasing emphasis on the needs of women in recent years. In December 2011 it released a draft guidanc...
  • Feature ArticlesFeature Articles

    Participation of Women in Clinical Trials: Ethically Achieving Representative Enrollment

    • 26 November 2013
    Introduction Clinical trial safety and efficacy results are integral components of the marketing applications for new drugs, medical devices and biologics. The trials signal the possibility of new and improved therapies for the greater patient population and, very importantly, provide individuals suffering from a disease with an opportunity to receive potentially effective new therapy, particularly in Phase 3 trials. Twenty years have passed since progressive regulatory ...
  • Are Medical Devices Meeting the Needs of Women?

    The US Food and Drug Administration's (FDA) device regulatory division wants to know: Are medical devices meeting the unique needs of women? That question is behind a newly announced workshop the agency's Center for Devices and Radiological Health (CDRH) plans to hold in June 2013 entitled, "The Health of Women (HoW) Program: Educate, Enable, Enlist and Explore-HoW to Improve the Health of Women." Background FDA has in the last two years announced at least one initiati...