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New FDA Guidance to Industry published as final

On July 24, FDA released a final Guidance to Industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics”.

This release follows the initial publication for public review in draft form on February 19, 2014, and replaces the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and the 1987 FDA Guidance for Industry on "Submitting Samples and Analytical Data for Methods Validation."

It provides recommendations on how the applicant can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

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