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Studies for approval of new drugs have insufficient patients to evaluate safety
Date:3/19/2013

p>They conclude: "In light of new scientific and legislative tools to monitor benefits and risks in clinical use, discussion of the long-term exposure requirements for approval of medicines, particularly for medicines intended for chronic use, seems warranted."

The authors add: "Such a discussion should involve healthcare providers, patients, and academia, as well as industry and regulators, and should include debate on the level of acceptable uncertainty, especially for adverse events and the long-term outcomes for chronic medication."


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Contact: Sumrina Yousufzai
syousufzai@plos.org
415-568-3164
Public Library of Science
Source:Eurekalert

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