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FDA Guidance for Industry ANDA Submissions; Refuse to Receive Standards - 19 Nov 2013

 The FDA in October 2013 published the Refuse-to-Receive Standards Guidance for Industry concerning ANDA submissions.  The guidance describes what should be included in an ANDA and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA.  A refuse-to-receive decision indicates that FDA has determined that an ANDA is incomplete on its face, usually because of omissions.  This guidance is not meant to be all-inclusive and does not offer explicit guidance on minor deficiencies that may be found in an ANDA submission.  FDA currently is applying many of these standards in its refuse-to-receive determinations.

This guidance is organized according to FDA’s ANDA Filing Checklist for Completeness and Acceptability of an Application (ANDA checklist), which is an internal checklist FDA reviewers use when evaluating the completeness of ANDAs. FDA makes the ANDA checklist available to the public for transparency purposes and to help sponsors gain an understanding of FDA’s review process.

This guidance is intended to assist sponsors preparing to submit to the Food and Drug Administration (FDA) abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product. 

Consequently, any entity intending to file an ANDA is impacted by this guidance as it became effective in October 2013.  FDA’s ANDA checklist captures the essential statutory and regulatory requirements for receiving ANDA submissions. The ANDA checklist is formatted to mirror the organization of the Electronic Common Technical Document (eCTD), and it can be downloaded from FDA’s website.

Note: The ANDA checklist is updated quarterly so if you are referring to the checklist, it is important to make sure you have the most up-to-date version.  This guidance describes what should be included in an ANDA submission.  It identifies and explains deficiencies that would lead FDA to refuse to receive an ANDA.  The overall goal of this guidance is to help sponsors increase the quality of their ANDA submissions.

Follow this link to access the document:

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