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Satisfying the Regulatory Requirements for New Antidiabetic Drugs for Type 2 Diabetes Most Expeditiously

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Book cover Cardiovascular Safety in Drug Development and Therapeutic Use

Abstract

The regulatory landscapes for the prospective exclusion of unacceptable cardiovascular risk associated with new antidiabetic drugs for type 2 diabetes in the USA and Europe were formalized in 2008 and 2012, respectively. The FDA’s Guidance for Industry specifically addressing this landscape was issued in final format (a rare occurrence) in December 2008 (FDA 2008). The EMA’s updated general guidance document addresses this topic. Following the release of a first draft in 2010 and a revised draft in 2011 (a period for public comment followed each release), the document was finalized in May 2012 and became effective in November 2012 (EMA 2012). The first section of this chapter presents the key aspects of each document.

There is considerable interest among many stakeholders regarding ways in which the existing regulatory requirements can be met more efficiently.

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Author information

Authors and Affiliations

  1. Cardiac Safety Services Quintiles, Durham, North Carolina, USA

    J. Rick Turner (Chief Scientific Advisor)

  2. Research Team, Cardiac Safety Services Quintiles, Mumbai, India

    Dilip R. Karnad (Head)

  3. Cardiac Safety Services Global Head, Cardiac Safety Center of Excellence Quintiles, Mumbai, India

    Snehal Kothari (Chief Medical & Scientific Officer)

Authors
  1. J. Rick Turner
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  2. Dilip R. Karnad
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  3. Snehal Kothari
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Turner, J.R., Karnad, D.R., Kothari, S. (2017). Satisfying the Regulatory Requirements for New Antidiabetic Drugs for Type 2 Diabetes Most Expeditiously. In: Cardiovascular Safety in Drug Development and Therapeutic Use. Adis, Cham. https://doi.org/10.1007/978-3-319-40347-2_13

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  • DOI: https://doi.org/10.1007/978-3-319-40347-2_13

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  • Publisher Name: Adis, Cham

  • Print ISBN: 978-3-319-40345-8

  • Online ISBN: 978-3-319-40347-2

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