Abbreviated New Drug Applications (ANDAs) are improving overall in content and submission format, but errors made due to not keeping up with changing requirements and applicants taking too long to respond to filing deficiencies found by reviewers are delaying some approvals, FDA’s Office of Generic Drugs (OGD) is reporting.
OGDs “filing review checklist” – the standard reviewers use to judge the completeness and acceptability of an ANDA – is being updated quarterly based on input from the review divisions, and reflects what reviewers expect to see in the applications.
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OGDs “filing review checklist” – the standard reviewers use to judge the completeness and acceptability of an ANDA – is being updated quarterly based on input from the review divisions, and reflects what reviewers expect to see in the applications.
"At the annual GPhA/FDA Fall Technical Conference in October in Bethesda, Maryland, OGD Regulatory Support Management Officer Kwadwo Awuah told attendees that he “strongly recommends” checking the list before submitting an application “because there will be certain changes that will be made every quarter and we expect any application that comes in to have those changes.”
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