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Abortion Advocates Brace For Impact As SCOTUS EMTALA Case Looms

Women’s rights advocates, providers and other stakeholders are raising concerns that the consolidated pair of impending Supreme Court cases up for oral arguments Wednesday (April 24) could have dire consequences for emergency medical protections and access to stabilizing treatment.

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Study: Researchers Seek Help From FDA To Fill Clinicaltrials.gov Gaps

A report co-sponsored by FDA suggests many clinical trial sponsors want the agency’s help on how to comply with the reporting requirements for HHS’ clinical trials database, Clinicaltrials.gov -- a database suffering from significant gaps and over which FDA has enforcement responsibility.

Reagan-Udall Launches Real-Word Evidence Collaboration For Sickle Cell Disease

FDA's Regan-Udall Foundation and the ASH Research Collaborative (ASH RC) are launching a collaborative project to gather real-world evidence for sickle cell disease, aiming to establish a consensus on using electronic health record data to better understand clinical outcomes among sickle cell patients and broaden research in the field.

Burgess: Site Neutral Policies Key To Stable Doc Pay, Lower Overall Costs

Implementing site-neutral Medicare payment policies could replace the budget neutrality requirements that have driven cuts to physician pay while supporting independent practices and lowering overall health care costs for the American people,

HRSA Cements Revisions For Improved 340B Dispute Resolution

The Health Resources and Services Administration (HRSA) has finalized modifications to the Administrative Dispute Resolution (ADR) process associated with the federal 340B drug discount program that are aimed at ensuring the process is less “trial-like” and more accessible to all stakeholders involved.

Cassidy Skeptical Of FDA’s Approach To CDS Software Regulation

The top Republican on the Senate health committee is criticizing FDA’s approach to regulating clinical decision support (CDS) software, asking the agency for more information about how it crafted its guidance on the technology and whether it has documentation of threats posed to patients.