Regulatory Focus™ > News Articles > New Draft Guidance on Developing Drugs for UTIs

New Draft Guidance on Developing Drugs for UTIs

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New draft guidance from the US Food and Drug Administration (FDA) aims to assist sponsors and pharmaceutical manufacturers in the development of drugs to treat complicated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:

  • benefit:risk
  • pharmacokinetic
  • clinical trial designs
  • special populations
  • dose selection and formulation
  • compatarot products
  • endpoints
  • clinical trial procedures
  • statistical considerations
  • labeling

Comments on the draft guidance are due by 24 May 2012.


Read more:

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Federal Register Posting - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment; Availability


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