FDA Updates Guidance On Lab Data For New Drugs

Law360, New York (February 19, 2014, 8:43 PM EST) -- The U.S. Food and Drug Administration on Wednesday updated its expectations for how drugmakers determine the strength, purity and chemical composition of their proposed products, describing how testing methods should be selected and explained to regulators.

In its draft guidance, the FDA focused on so-called analytical procedures — essentially, lab tests that evaluate a drug’s attributes. The document applies to most forms of approval applications, including those for new brand-name drugs, generics and biologics.

The guidance is expected to supersede policies previously outlined in 2000, and...
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