The FDA and the new biology.

Robert D. Simari, Horng Chen, John C. Burnett

Research output: Contribution to journalEditorialpeer-review


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
Issue number4
StatePublished - Dec 2008

ASJC Scopus subject areas

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


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