FDA Issues Guidance Documents to Streamline Premarket Review and Approval…
The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…
Author
CMS Releases Additional Information about the Cell and Gene Therapy (CGT)…
The Centers for Medicare and Medicaid Innovation (CMMI) previously released three new payment models, all aimed at lowering drug…
John Crowley Steps up as BIO CEO
Recently, the Biotech Innovation Organization (BIO) announced a new CEO, John Crowley. Crowley is the co-founder of Amicus…
Evaluation on NGACO Model Finds Spending Reductions Grow Over Time
The United States Centers for Medicare and Medicaid Services (CMS) recently funded a report by NORC at the University of Chicago,…
CMS Issues Interoperability and Prior Authorization Final Rule
Early this year, the United States Centers for Medicare and Medicaid Services (CMS) issued a final rule on Interoperability and…
CMS Issues CY 2025 Advance Notice, AMGA Raises Concerns
Recently, the United States Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2025 Advance Notice…
Vanda Lawsuit Against United States for Uncompensated Taking Allowed to…
The United States Court of Federal Claims in Washington, D.C. recently denied the United States’ motion to dismiss Vanda…
CMS Seeks Input on Medicare Advantage Data
Recently, the United States Centers for Medicare and Medicaid Services (CMS) issued a Request for Information regarding various…
HHS Releases Working Paper on Supporting Cybersecurity in Healthcare
The Department of Health and Human Services released a working paper that outlines its strategy to support cybersecurity in…
Biden Administration Announces Initiatives Aimed at Promoting Competition…
On December 7, 2023, the Biden Administration announced several new initiatives intended to “promote competition” in the health…