title: Current and future state of FDA-CMS parallel reviews.
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.
authors.affiliation: Center for Medical Technology Policy, World Trade Center-Baltimore, Baltimore, Maryland, USA. donna.messner@cmtpnet.org
authors.forename: D A
authors.initials: DA
authors.lastname: Messner
authors.forename: S R
authors.initials: SR
authors.lastname: Tunis
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D003257:Consumer Product Safety / Q000592:standards*; D017277:Drug Approval / Q000191:economics / Q000458:organization & administration; D004345:Drug Industry / Q000191:economics / Q000592:standards; D005544:Forecasting; D019981:Health Care Sector / Q000191:economics / Q000592:standards*; D006801:Humans; D019458:Insurance Coverage / Q000191:economics; D007880:Legislation, Drug / Q000191:economics / Q000458:organization & administration / Q000592:standards*; D006278:Medicare / Q000191:economics; D004364:Pharmaceutical Preparations / Q000191:economics / Q000592:standards*; D011366:Professional Review Organizations / Q000191:economics / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations