Premium
Current and Future State of FDA‐CMS Parallel Reviews
Author(s) -
Messner D A,
Tunis S R
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2011.350
Subject(s) - food and drug administration , medicaid , incentive , clinical pharmacology , product (mathematics) , business , medicine , pharmacology , political science , economics , law , health care , geometry , mathematics , microeconomics
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. Clinical Pharmacology & Therapeutics (2012); 91 3, 383–385. doi: 10.1038/clpt.2011.350