SWHR Regulatory Policy

SWHR champions policies to improve the health of women across the lifespan. As part of its efforts throughout the year, the Society responds to federal agencies’ Requests for Information (RFIs) that could have important ripple effects on the research enterprise or those that present an opportunity to elevate or promote the unique needs of women.

SWHR Responds to RFI on Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights

The Society for Women’s Health Research (SWHR) responded to a Request for Information (RFI) from the NIST

SWHR Responds to RFI on Clinical Research Infrastructure and Emergency Clinical Trials

SWHR submitted comments to the White House Office of Science and Technology Policy (OSTP) on a Request for Information (RFI)...

SWHR Submits Comments to MEDCAC on CMS General Requirements for Clinical Studies Under CED

The Society for Women’s Health Research submitted comments to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel in...

SWHR Responds to NIH RFI on NIH-Wide Strategic Plan for Research on the Health of Women

The Society for Women’s Health Research responded to a Request for Information (RFI) from the National Institutes of Health (NIH)...

SWHR Provides Comments to CMS on NCA on Beta Amyloid PET in Dementia and Neurodegenerative Disease

SWHR provided comments to the Centers for Medicare and Medicaid Services (CMS) on its reconsideration of the National Coverage Determination...

SWHR Responds to NIH Request for Information on Intersection of COVID-19 Pandemic and Health of Women

The Society for Women’s Health Research provided feedback to the National Institutes of Health (NIH) Office of Research on Women’s...

SWHR Provides Comments on NIH-Wide Strategic Plan for DEIA

The Society for Women’s Health Research provided comments to the National Institutes of Health on its Request for Information: Inviting...

SWHR Responds to OSTP Request for Information on Strengthening Community Health Through Technology

The Society for Women’s Health Research responded to the White House Office of Science and Technology Policy (OSTP) Request for...

SWHR Provides Comments to CMS on Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of AD

The Society for Women’s Health Research provided comments to the Centers for Medicare & Medicaid Services (CMS) in response to...

SWHR Comments to NIH on Draft COSWD Strategic Plan (FYs 22-26)

The Society for Women’s Health Research provided comments in response to the Request for Information: Inviting Comments and Suggestions on...

SWHR Provides Input on USPSTF Draft Research Plan on Cervical Cancer Screening

The Society for Women’s Health Research shared input with the U.S. Preventive Services Task Force (USPSTF) on its Draft Research...

SWHR Responds to RFI to Inform the Women’s Health Consensus Conference

The Society for Women’s Health Research provided input on the current state of women’s health research at the National Institutes...

SWHR Comments to NCI on Enhancing Diversity and Inclusion

The Society for Women’s Health Research provided a response to NCI’s Request for Information on how to enhance diversity and...

SWHR Comments to USPSTF on Menopausal Hormone Therapy Research Plan

SWHR President & CEO Kathryn G. Schubert submitted comments to the U.S. Preventive Services Task Force (USPSTF), on the Task...

SWHR Urges Biden Administration to Extend Postpartum Medicaid Coverage

SWHR signed onto a letter urging swift action from the Centers for Medicare and Medicaid Services (CMS) to extend the...

SWHR Comments on Sex & Gender Considerations in NIH-Wide COVID-19 Strategic Plan

SWHR submitted comments in response to the recently released NIH-Wide Strategic Plan for COVID-19 Research.

SWHR Supports FDA Recommendations to Include Younger Women in Breast Cancer Research

SWHR submitted comments in response to a newly released FDA draft guidance for industry, which provides recommendations regarding the inclusion...

SWHR Comments to FDA on MDUFA Reauthorization for Fiscal Years 2023-2027

SWHR submitted comments to the FDA regarding the proposed recommendations for the reauthorization of the Medical Device User Feed Act...

SWHR Urges FDA OWH to Prioritize Inclusion of Pregnant Women in Clinical Trials

SWHR signed on to a comment letter from the Coalition to Advance Maternal Therapeutics (CAMT) regarding the inclusion of pregnant...

SWHR Recommendations to FDA OWH on Strategic Priorities

SWHR submitted comments on the FDA Office of Women’s Health’s strategic priorities.

SWHR Recommendations to FDA for PDUFA Reauthorization for FY 2023-27

SWHR provided comments to the FDA regarding the proposed recommendations for the reauthorization of the Prescription Drug User Fee Act...

SWHR Feedback to NIH on Improving Biomedical Animal Research

SWHR provided comments to NIH on methods of improving animal research, highlighting the importance of sex as a biological variable...

SWHR Comments to NIA on Alzheimer’s Research Gaps and Opportunities

SWHR provided feedback in response to the National Institute of Aging’s request for information regarding Alzheimer’s and dementia-related research gaps...

SWHR Urges Inclusion of Expanded Pregnancy-Related Medicaid Coverage in COVID-19 Legislation

SWHR signed on to a letter urging Congressional leadership to include H.R. 4996, the Helping MOMS Act, in forthcoming COVID-19...

SWHR Comments to NIDA on Strategic Plan for FYs 2021-2025

SWHR provided input to the NIDA on its Strategic Plan Outline for Fiscal Years 2021-2025, including the need to address...

SWHR Urges Biden Administration to Extend Postpartum Medicaid Coverage

SWHR signed onto a letter urging swift action from the Centers for Medicare and Medicaid Services (CMS) to extend the...

SWHR Comments to CDC on Management of Acute and Chronic Pain

SWHR provided the Centers for Disease Control and Prevention (CDC) with requested comments on Management of Acute and Chronic Pain.

SWHR Comments on AHRQ Draft Report on Dementia Caregiving

SWHR provided comments on the Care Interventions of People with Dementia and for their Caregivers draft report by the Agency...

SWHR Feedback to FDA on Health of Women Strategic Plan

In comments to the FDA Center for Devices and Radiological Health, SWHR provided feedback on the strategic plan for the...

SWHR Praises FDA Draft Guidance on Lactation Study Design

SWHR praised the Food and Drug Administration (FDA) for its draft guidance to industry on pre- or post-marketing lactation studies.

SWHR Comments on FDA Draft Guidance on Post-Approval Pregnancy Safety Studies

SWHR provided comments to the Food and Drug Administration (FDA) on its recently released draft guidance pertaining pregnancy safety study...

SWHR Comments on HHS Task Force Pain Management Draft Report

SWHR provided comments in response to HHS’ Pain Management Best Practices Inter-Agency Task Force Draft Report.

SWHR Input on NICHD Strategic Plan for FY2020-2024

SWHR comments on NICHD strategic plan for fiscal years 2020-2024, emphasizing a need for including diverse populations within human development...

SWHR Expresses Concerns About CMS Guidance for Next Generation Sequencing

SWHR releases comments on CMS guidance for Next Generation Sequencing (NGS), urging CMS to clarify coverage policies for NGS.

SWHR Response to NHLBI Women’s Health Working Group

SWHR responds to NHLBI Women's Health Working Group, following the WHWG request for information regarding sex and gender differences in...

SWHR Encourages Inclusion of Women’s Voices in Patient-Focused Drug Development

SWHR provides feedback on the FDA's Patient-Focused Drug Development workshop, stressing the need for greater emphasis on diversity within the...

SWHR Expresses Concerns Regarding CMS Step Therapy Proposal

SWHR expresses concern over recent CMS step therapy proposal that would allow MA plans to implement step therapy within the...

SWHR Comments on FDA Guidance on Pregnant Women in Clinical Trials

SWHR submitted comments and suggested additions to FDA draft guidance focusing on the inclusion of pregnant women in clinical trials.

SWHR Contributes to Patient-Focused Drug Development Workshop

SWHR comments on recent FDA Patient-Focused Drug Development workshop regarding best practices for data collection and gathering patient input.

SWHR Concerns on Clinical Laboratory Fee Schedule

SWHR expressed serious concerns regarding the 2018 Clinical Laboratory Fee Schedule (CLFS) final payment rates.

SWHR Input on NIH Strategic Plan for Women’s Health Research

SWHR provided input on the National Institutes of Health (NIH) strategic plan for research on women’s health.

SWHR Signs On to Letter on Proposed Medicare Part B Changes

SWHR signed onto a letter to the Medicare Payment Advisory Commission on reconsidering the proposed Medicare Part B changes. 

SWHR Comments on USPSTF Draft Recommendations for Sleep Apnea Screening

SWHR's Sleep Network provided comments to the U.S. Preventive Services Task Force on its draft recommendation on screening for sleep...

Additional Policy and Advocacy Engagement

Check out more of SWHR’s efforts to bolster women’s health across the federal government.

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