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Results: 1-10 of 144

A&B healthcare week in review, July 24, 2015: Regulations, notices, & guidance
  • Alston & Bird LLP
  • USA
  • July 24 2015

On July 24, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the extension of temporary moratoria on the enrollment of new


Update on biosimilar reimbursement pathways: CMS guidance and outstanding issues
  • Alston & Bird LLP
  • USA
  • July 10 2015

Earlier this year, the U.S. Food and Drug Administration (FDA) approved the first biosimilar in the United States. The Centers for Medicare &


FDA: artificial trans fats in partially hydrogenated oils are on the way out
  • Alston & Bird LLP
  • USA
  • June 18 2015

This week, the U.S. Food and Drug Administration ("FDA") announced that food manufacturers have three years to stop using partially hydrogenated oils


A&B healthcare week in review, April 10, 2015: Regulations, notices, & guidance
  • Alston & Bird LLP
  • USA
  • April 10 2015

On April 10, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled "Medicare and Medicaid Programs; Electronic


Biosimilar reimbursement pathways: CMS guidance and outstanding issues
  • Alston & Bird LLP
  • USA
  • April 6 2015

On March 6, 2015, the U.S. Food and Drug Administration (FDA) approved the first biosimilar in the United States. The Centers for Medicare & Medicaid


Urgent safety alert
  • Alston & Bird LLP
  • USA
  • January 16 2015

The U.S. Food & Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) currently are investigating multiple instances of


FDA rejects ban on sweetener aspartame
  • Alston & Bird LLP
  • USA
  • November 7 2014

Last week, the U.S. Food and Drug Administration (FDA) declined to ban the popular sweetener additive, aspartame, stating that it had found no


FDA finalizes cybersecurity guidance for medical devices
  • Alston & Bird LLP
  • USA
  • October 15 2014

Earlier this month, the U.S. Food & Drug Administration (FDA) issued a final guidance on the management and mitigation of cybersecurity risks in the


FDA issues Final Cybersecurity Guidance
  • Alston & Bird LLP
  • USA
  • October 10 2014

On October 2, 2014, the U.S. Food and Drug Administration (FDA) took another critical step towards mitigating and managing cybersecurity threats by


More gluten-free micro-brews in our future?
  • Alston & Bird LLP
  • USA
  • August 14 2014

The U.S. Food and Drug Administration (FDA) issued a Final Rule last August establishing a federal standard for "gluten-free" labeling of foods. That