As an initial matter, FDA guidance documents—including the guidance document included with this Alert—do not create legally enforceable rights or responsibilities.
The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products ("FDA stability guidance") that was published in the Federal Register on September 25, 2012. It also incorporates comments received on the same draft, which were previously published in the Federal Register on August 27, 2013.
As an initial matter, FDA guidance documents—including the guidance document included with this Alert—do not create legally enforceable rights or responsibilities. Rather, this guidance only represents FDA's current thinking on a topic, and should be read only as containing recommendations, unless specific regulatory or statutory requirements are cited.
In summary, the attached guidance addresses issues related to drug master files (DMFs) and drug product manufacturing and packaging. It also includes a discussion of stability studies, which is intended to clarify the stability testing data recommendations for abbreviated new drug applications (ANDAs).
The final FDA stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505(j) and DMFs (Type II for drug substances that support the ANDAs). The final guidance was published on June 20, 2013, with an implementation date of June 20, 2014. It does not apply to postapproval changes.
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