Current and future state of FDA-CMS parallel reviews

D. A. Messner, S. R. Tunis

Research output: Contribution to journalArticlepeer-review

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 languageEnglish (US)
Pages (from-to)383-385
Number of pages3
JournalClinical Pharmacology and Therapeutics
Volume91
Issue number3
DOIs
StatePublished - Mar 2012
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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