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Anda Checklist Form

Anda Checklist Form

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Instructions and help about Anda Checklist

hello my name is james hanratty i'm a regulatory counsel in the center for drug evaluation and research today i'm going to be presenting on the guidance for industry referencing approved drug products and andis admissions first i wanted to go over the purpose and the goals of the guidance the main goal is to help applicants submitting an abbreviated new drug application in anda to seek approval of a generic drug to be able to identify a reference listed drug also known as an rld which is a previously approved drug product on which an applicant relies on seeking approval of a generic drug also to be able to identify the reference standard and that's a previously approved drug product selected by the fda that an applicant must use in conducting any in vivo bio equivalence testing required to support the approval of the anda and finally to be able to identify the basis of submission for ananda let's take a step back and talk about the statutory background for generic drugs section j of th

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