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FDA Releases Facility Readiness Guidance

June 21, 2024

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FDA published a final guidance document on June 18, 2024 that provides applicants with information on FDA’s policy for assigning a goal date for a facility’s inspection readiness as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). The way the agency incorporates a program enhancement agreed upon by both the agency and industry is explained in the guidance document.

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