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Congress Intensifies Tampon Safety Efforts and FDA Takes Steps to Respond

In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia,...more

CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive...

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more

FDA Issues Guidance Intended to Diversify and Enhance Clinical Trial Participation

On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the...more

New Biden Executive Order Emphasizes Women’s Health

Following an initial funding announcement last month, the Biden administration has kept its foot on the gas to build out the White House Initiative on Women’s Health Research. Last month, we wrote about ARPA-H’s $100 million...more

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