The US Food and Drug Administration (FDA) has revised its guidance on timeframes for responding to complete response letters (CRL) to abbreviated new drug applications (ANDA) based on commitments in the latest generic drug user fee program. Under the latest deal, minor amendments that have not been addressed within a year of the CRL will be reclassified as major amendments.
The agency published the revised guidance on 14 December, only 5 months after first issuing the ANDA CRL guidance. The revision is meant to reflect new commitments agreed upon between the generic drug industry and FDA under the third iteration of the Generic Drug User Fee Amendments (GDUFA III). (RELATED: FDA finalizes ANDA CRL, Orange Book Q&A guidances, Regulatory Focus 27 July 2022)
“As described in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on previous authorizations of GDUFA,” the agency said. “New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent of reducing the number of assessment cycles for ANDAs and facilitating timely access to generic medicines for American patients.”…
