FDA Releases Draft Guidance on Abbreviated New Drug Applications Submissions and Amendments

Summary

The FDA has announced the availability of a draft guidance document that explains how the agency will review amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) submitted under the Generic Drug User Fee Act (GDUFA). The guidance aims to clarify the review goals established by the GDUFA II Reauthorization of 2017 and how they apply to amendments submitted prior to October 1, 2017.