Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA) under the Generic Drug Use Fee Amendments (GDUFA) to classify fewer deficiencies as “major” and avoid extended review cycles.
FDA established a docket to solicit public comments on Appendix A of the July 2018 guidance for industry on “ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.” The effort to solicit public comment was part of the GDUFA III Commitment Letter. The ANDA Amendments Guidance defines amendment classifications and categories and how they may impact an amendment’s performance goal date. Appendix A is focused on “major” deficiencies and provides a non-exhaustive list of examples. (RELATED: FDA Finalizes Guidance on GDUFA II, Regulatory Focus 3 July 2018)…
