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Posted 24 February 2012 | By Alexander Gaffney, RAC
New draft guidance from the US Food and Drug Administration (FDA) aims to assist sponsors and pharmaceutical manufacturers in the development of drugs to treat complicated urinary tract infections (cUTI).
The draft, Guidance for Industry: Complicated Urinary Tract Infections: Developing Drugs for Treatment, provides a comprehensive breakdown of both general and specific considerations necessary for developing cUTI products. These considerations include:
Comments on the draft guidance are due by 24 May 2012.
FDA - Guidance for Industry: Complicated Urinary Tract Infections: Developing Drugs for Treatment
Federal Register Posting - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment; Availability
Tags: Urinary Tract Infection, cUTI, UTI, Infection, Latest News, clinical trial, draft guidance
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...