The FDA and the new biology.

Research output: Contribution to journalArticle

Abstract

The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval.

Original languageEnglish (US)
Pages (from-to)246-247
Number of pages2
JournalJournal of Cardiovascular Translational Research
Volume1
Issue number4
StatePublished - Dec 2008

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United States Food and Drug Administration
Technology
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Genetics
  • Genetics(clinical)
  • Molecular Medicine
  • Pharmaceutical Science

Cite this

The FDA and the new biology. / Simari, Robert D.; Chen, Horng Haur; Burnett, John C Jr.

In: Journal of Cardiovascular Translational Research, Vol. 1, No. 4, 12.2008, p. 246-247.

Research output: Contribution to journalArticle

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