Pamela Mejia

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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

8/20/2024  /  Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , MACs , Medical Devices , Medicare , Notice Requirements , Reimbursements

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On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the...more

7/30/2024  /  Clinical Trials , Diversity , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Prescription Drugs

ARPA-H Commits $100 Million to Accelerate Women’s Health Research through Sprint for Women’s Health

On February 21, 2024, the Advanced Research Projects Agency for Health (ARPA-H) announced a $100 million commitment to research and development in women’s health through Sprint for Women’s Health, a first-of-its-kind effort....more

2/29/2024  /  Medical Devices , Medical Research , Women's Preventable Healthcare Mandates
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