Advertisement

What Should be Required for FDA Approvability of a New Antihypertensive Drug? What is the FDA’s Viewpoint?

  • R. Temple
Chapter
Part of the Developments in Cardiovascular Medicine book series (DICM, volume 112)

Abstract

I will try not to repeat what has been said earlier. The current guidelines and current policy on what is needed to market an antihypertensive drug are fairly clear. Antihypertensive drugs are approved on the basis of a demonstrated ability to lower blood pressure to a reasonable degree and a reasonably complete characterization of a drug’s pharmacokinetic and pharmacodynamic properties, with particular emphasis on dose-response and on patient characteristics that can alter this response. We have not, up to now, sought evidence of diminished end-organ damage or mortality for each new agent, relying instead on the past studies that showed such benefits of lowering blood pressure.

Keywords

Calcium Channel Blocker Antihypertensive Drug Lower Blood Pressure Central Nervous System Depression Physician Health Study 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Copyright information

© Kluwer Academic Publishers 1990

Authors and Affiliations

  • R. Temple
    • 1
  1. 1.Center for Drug Evaluation and Research, Office of Drug Evaluation IFood and Drug AdministrationRockvilleUSA

Personalised recommendations