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.
Original language | English (US) |
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Pages (from-to) | 383-385 |
Number of pages | 3 |
Journal | Clinical Pharmacology and Therapeutics |
Volume | 91 |
Issue number | 3 |
DOIs | |
State | Published - Mar 2012 |
Externally published | Yes |
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)