US FDA Refuse-to-Receive Guidance for Electronic ANDA Submissions

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Serious deficiencies in Abbreviated New Drug Applications (ANDAs) will trigger a refuse-to-receive response from the U.S. Food & Drug Administration, and require the applicant to file a new submission and pay an additional fee according to the latest Agency draft guidance.

Enhanced refusal-to-receive standards are one of the primary Year 1 program goals under the Generic Drug User Fee Act (GDUFA) which initiates a user fee structure for the generic drug industry and creates an informal mandate to submit ANDA applications electronically.

If the FDA determines that a submission contains fewer than 10 minor errors, a sponsor will have the opportunity to correct those deficiencies within five (5) business days. Sponsors won’t lose their place in line in this scenario, as the application is considered received on the date of first submission.

However, an application that is deemed to have 10 minor deficiencies or more, or one or more major errors will be treated as a brand new submission and forfeit its original filing date.

The FY2014 GDUFA fee to file an ANDA is $63,860 (effective October 1, 2013), a 24% increase from FY2013 adjusted for inflation. In accordance with previously released guidance, the FDA will refund 75% of the original filing fee in all instances of refuse-to-receive with the exception of failure to pay fees. Therefore, an application that is refused on the first attempt, amended, refiled and accepted for review would pay a total of $78,825, or 125% of the standard amount.ANDA_Chart

In a three-year span from 2009-2012, the Office of Generic Drugs (OGD) refused to receive 497 ANDAs. In 2012, OGD determined that 9.4% of applications contained enough errors to warrant a refuse-to-receive response. Of the 100 applications that received this designation in 2012, a large majority were determined to have scientific flaws such as bioequivalence or chemistry errors.

Regardless of the type of errors detected, the FDA emphasized a need for improvement in the quality of ANDA submissions.

“Despite the evidence that the majority of deficiencies are related to bioequivalence and product quality (chemistry, manufacturing, and controls – CMC) standards, FDA believes that clarification of all criteria will help improve the overall quality of ANDA submissions,” the organization stated in its Guidance for Industry.

The FDA publishes an ANDA checklist that sponsors can consult when compiling a submission. The checklist, updated quarterly, is formatted to mirror the organization of the Electronic Common Technical Document (eCTD).

Author: GS

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