"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications

When reviewing submitted applications for authorisation for generics the US Food & Drug Administration (FDA) pays attention to completeness and compliance with certain standards. If the applications do not meet the standards or are even incomplete, the FDA's "Office of Generic Drugs" (OGD) processing these applications denies their reception. The fact that the OGD had to reject in total 497 "Abbreviated new Drug Applications" (ANDA) in the period between 2009 and 2012, led the authority to publish a draft guidance for industry entitled "ANDA Submissions - Refuse-to-Receive Standards". This document was published in October 2013 and was released for comments for 30 days.

In the following main chapters the guidance explains the reasons that lead to the rejection of an application:

  • General guidelines
  • Error in the labelling
  • Incorrect type II active API Drug Master File and erroneous information concerning the active substance
  • Deficiencies in the CMC section of the application
  • Shortcomings with regard to bio-equivalence and clinical trials

In addition to incorrect information regarding the active ingredient or the excipients a delayed payment of fees can also result in a rejection of the application - even with an otherwise correctly set up dossier! The rules relating to fees for generic applications - GDUFA - which only became effective in October 2012, calls for the payment of fees until at least 20 days after filing. Since the FDA issues no bills, this period is sometimes forgotten (the authority already issued Warning Letters in this regard). The payment of the fees for a Drug Master File is equally important and necessary in accordance with GDUFA. If this fee was not paid, the DMF does not become available for the reference list and the generic authorisation application is handled as if the DMF were basically "non-existent".

The "facility fee" is another GDUFA fee to be paid per year. If it is not paid on time this also leads to the rejection of the application. This site fee was payable in March 2013 for the fiscal year 2013 and in October 2013 for the fiscal year 2014. A few days ago, the FDA has published a list of companies in relation to their GDUFA status. This GDUFA Facility Arrears List provides information about which companies have already paid or are no longer subject to charges. A more current list shows all companies that have done their duty after self identification (also a demand of GDUFA). This "Self Identified Facilities List" for the fiscal year 2014 lists a total of 3777 sites with complete address.

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