Current and future state of FDA-CMS parallel reviews

Clin Pharmacol Ther. 2012 Mar;91(3):383-5. doi: 10.1038/clpt.2011.350.

Abstract

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

MeSH terms

  • Centers for Medicare and Medicaid Services, U.S.*
  • Consumer Product Safety / standards*
  • Drug Approval / economics
  • Drug Approval / organization & administration
  • Drug Industry / economics
  • Drug Industry / standards
  • Forecasting
  • Health Care Sector / economics
  • Health Care Sector / standards*
  • Humans
  • Insurance Coverage / economics
  • Legislation, Drug / economics
  • Legislation, Drug / organization & administration
  • Legislation, Drug / standards*
  • Medicare / economics
  • Pharmaceutical Preparations / economics
  • Pharmaceutical Preparations / standards*
  • Professional Review Organizations / economics
  • Professional Review Organizations / standards*
  • United States
  • United States Food and Drug Administration*

Substances

  • Pharmaceutical Preparations