In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A guidance document represents the current thinking and recommendations of the FDA, but is not legally binding.
The Guidance Document explains how amendment submissions in response to FDA’s assessment of the ANDA, communicated via a Complete Response Letter (CRL), may affect an application’s review goal dates (i.e., the time it will take FDA to respond to an ANDA Amendment). In short, amendments to an ANDA will be designated as “standard” or “priority” and classified as “major” or “minor." FDA will assign a goal date depending on the amendment’s assigned designation and classification, and other factors discussed in the guidance, such as whether a facility inspection will be required as a result of the content of the amendment or if the ANDA applicant also submits unsolicited amendments to its ANDA.
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