FDA Releases ANDA Submission Guidance

July 3, 2018
Pharmaceutical Technology Editors

The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.

On July 3, 2018, FDA released final guidance regarding the submission of amendments to abbreviated new drug application (ANDA) submissions. The guidance document is intended to explain how the review goals in the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to ANDA submissions or prior approval supplements (PASs).

Amendment classifications and categories are discussed in the document. The guidance also explains how amendment submissions may affect review goal dates. FDA’s assessment of amendments submitted to ANDAs and PASs received prior to October 1, 2017 is also addressed. An appendix provides examples of deficiencies that FDA may consider to be major.

Source: FDA