FDA Releases Final ANDA Submission Guidance

• By: Staff Editor
• Date: October 19, 2016
• Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf

The US Food and Drug Administration (FDA) published a final guidance on October 14, 2016 describing how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to prior approval supplements (PAS) submissions. The guidance also explains the amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).