FDA Guidance Explains Nuances of Making Changes to Generic Drug Submissions

Regulatory NewsRegulatory News | 11 July 2014 |  By 

A new draft guidance document published yesterday by the US Food and Drug Administration (FDA) aims to clarify what sponsors of generic drug applications can expect when they file amendments or make corrections to their already-submitted application.

The draft guidance, ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA, is meant for any sponsor of an abbreviated new drug application (ANDA)—used to approve generic drugs—that is looking to make a change to an already-submitted application.

Those changes are made through a multi-faceted amendment process that, like full applications, is generally subject to performance metrics under the Generic Drug User Fee Act (GDUFA) of 2012.

On 10 July 2014, FDA released another guidance document, ANDA Submissions — Prior Approval Supplements Under GDUFA, which explained which changes to an application were subject to GDUFA performance metrics. What that guidance left out, however, was any explanation of how quickly FDA would review various types of amendments.

A Matter of Time

FDA's newest guidance document, however, does explain how quickly sponsors can expect to hear back from FDA after submitting a specific type of amendment.

Those amendments fall under three categories: Tier 1, 2 and 3. Those tiers are then divided into two parts: Amendments solicited by FDA through a complete response letter (CRL) and those submitted by a sponsor without solicitation by FDA.

FDA's Tier Classification System for ANDA Amendments
 Solicited Amendment GoalsUnsolicited Amendment Goals
Tier 11st  Major: 10 months


1st – 3rd Minor: 3 months*

4th – 5th Minor: 6 months*

Delaying action or otherwise would eventually be solicited: 3 months*
Tier 2N/AAmendment not arising from “delaying action”: 12 months
Tier 3≥ 2nd Major: No goal


≥ 6th Minor: No goal

*As explained in FDA's previous guidance, if FDA needs to conduct a site inspection, the amendment will take as long as 10 months to review.

Regulatory Definitions

FDA's guidance also describes the difference between "major" and "minor" amendments.

"Major amendments contain a substantial amount of new data or new information not previously submitted to or reviewed by FDA, requiring, in FDA’s judgment, a substantial expenditure of FDA resources," FDA explained. Conversely, minor amendments are those which require fewer resources, but still enough to warrant staff review resources.

There is also a third category of deficiency known as an "easily correctable deficiency" (ECD). The review of these deficiencies requires only a "modest expenditure of FDA resources," and should require little effort on the part of a sponsor to correct.

Elsewhere, the guidance defines what a "delaying" amendment or action is. Such actions require FDA to slow or halt their review of an existing application, such as when the US Pharmacopoeia updates its monograph for a particular product or when a sponsor files a citizen petition with FDA over approval requirements. FDA notes that it has "broad discretion" about what constitutes a "delay."

Comments on the draft guidance are due to FDA by 9 September 2014.


ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA ( FR)


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