FDA Floats Drug Assessment Guidelines For Pharma Cos.

Law360, New York (September 12, 2013, 1:19 PM EDT) -- The U.S. Food and Drug Administration on Tuesday proposed updated guidelines for pharmaceutical companies on scientific methods they should use to evaluate their planned drugs for which they are submitting applications. 

The guidance relates to bioanalytical method validation, which affects laboratory procedures used in assessing drugs, including chromatography — a technique used to separate mixtures — and other detection methods, according to the agency.

The FDA’s guidance involves only recommendations, and not legal requirements, according to the agency. The FDA first issued the guidance in 2001...
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