Today FDA published a draft guidance entitled Field Alert Report Submission: Questions and Answers. Field Alert Report (FAR) regulations establish an early warning system to protect patient health. Under these regulations, applicants must submit certain product quality information regarding distributed drug products. Specifically, FARs concern information that may cause a drug product or its labeling to be mistaken for another article, or information related to contamination, significant chemical or physical changes or deterioration, or failure of distributed batches to meet specifications.
This guidance provides the agency’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help increase their consistency and relevancy. The guidance also addresses certain frequently asked questions and provides additional clarifications regarding FAR submissions. Additional information, including an electronic form to facilitate FAR submissions, is available on FDA’s FAR webpage.
To comment on the draft guidance, please visit the public docket, FDA-2018-D-2326.
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