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Not Keeping Current with Changing FDA Requirements and Slow Responses are Causing ANDA Approval Delays

Jan 7th, 2012

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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.

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.”

Awuah also urged firms to try and decrease the time that OGD spends waiting for responses for the filing deficiencies reviewers have noted.  “Most of them are minor and can be turned around in a few days,” he advised.  “We have a set 10 business day time limit – if we do not receive it within 10 business days, then we take appropriate action.”

In addition to reviewing the most recent changes made to the filing review checklist in detail, Awuah discussed:  ● trends in ANDA submissions ● reasons for “refuse to receive” (RTR) letters, and ● advice from reviewers on how to improve ANDA filings and speed application clearance.

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Also see related story:

Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

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