In anticipation of the reauthorization of the Generic Drug User Fee Amendment (known as GDUFA II), the Food and Drug Administration (FDA) is seeking assistance in identifying approved abbreviated new drug application (ANDA) sponsors and their affiliates. This information will be used to accurately determine the FY 2018 GDUFA program holder fee.
To provide input, please follow the instructions posted in the Federal Register Notice: https://www.federalregister.
gov/documents/2017/01/09/2017- 00081/generic-drug-user-fee- amendments-ii-program-fee- list-of-abbreviated-new-drug- application-sponsors
The public docket is available at: https://www.regulations.