Soliciting Public Comment on Appendix A of the Food and Drug Administration's July 2018 Guidance Entitled “Abbreviated New Drug Application Submissions-Amendments To Abbreviated New Drug Applications Under Generic Drug User Fee Amendments;” Notice; Establishment of a Public Docket; Request for Comments

Короткий зміст

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit comments on the content of Appendix A in the July 2018 guidance for industry entitled "ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA" (ANDA Amendments Guidance). We are soliciting comments on the content of Appendix A. The Agency is taking this action to fulfill the Agency's commitment described in section IX.B. of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 Commitment Letter (GDUFA III Commitment Letter).