DTC FDA Issues Guidance Documents on Direct-to-Consumer Advertisements Thomas Sullivan Apr 4, 2024 0 To increase transparency and consumer awareness, the Food and Drug Administration (FDA) issued a final rule to amend its…
FDA FDA Authorizes Florida Preliminary Clearance to Import Drugs from Canada Thomas Sullivan Apr 3, 2024 0 For the first time, the Food and Drug Administration has authorized a state to import prescription drugs from Canada, granting…
FDA FDA Issues Guidance Documents to Streamline Premarket Review and Approval… Thomas Sullivan Apr 2, 2024 0 The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…
CMS CMS Releases Additional Information about the Cell and Gene Therapy (CGT)… Thomas Sullivan Apr 1, 2024 0 The Centers for Medicare and Medicaid Innovation (CMMI) previously released three new payment models, all aimed at lowering drug…
Innovation John Crowley Steps up as BIO CEO Thomas Sullivan Mar 29, 2024 0 Recently, the Biotech Innovation Organization (BIO) announced a new CEO, John Crowley. Crowley is the co-founder of Amicus…
Accountable Care Organizations Evaluation on NGACO Model Finds Spending Reductions Grow Over Time Thomas Sullivan Mar 28, 2024 0 The United States Centers for Medicare and Medicaid Services (CMS) recently funded a report by NORC at the University of Chicago,…
CMS CMS Issues Interoperability and Prior Authorization Final Rule Thomas Sullivan Mar 27, 2024 0 Early this year, the United States Centers for Medicare and Medicaid Services (CMS) issued a final rule on Interoperability and…
CMS CMS Issues CY 2025 Advance Notice, AMGA Raises Concerns Thomas Sullivan Mar 26, 2024 0 Recently, the United States Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2025 Advance Notice…
FDA Vanda Lawsuit Against United States for Uncompensated Taking Allowed to… Thomas Sullivan Mar 25, 2024 0 The United States Court of Federal Claims in Washington, D.C. recently denied the United States’ motion to dismiss Vanda…
CMS CMS Seeks Input on Medicare Advantage Data Thomas Sullivan Mar 22, 2024 0 Recently, the United States Centers for Medicare and Medicaid Services (CMS) issued a Request for Information regarding various…