The FDA has released a draft guidance which is intended to assist sponsors preparing to submit to the Food and Drug Administration (FDA) abbreviated new drug applications (ANDAs) and prior approval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.
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 isapplying many of these standards in it 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.