The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User Fee Act (GDUFA III) program. One guidance covers FDA’s criteria for assigning a review goal date based on facility’s readiness for inspection, and the other addresses the early assessment of drug master files (DMFs) prior to the submission of generic drug applications.
These program enhancements were specified in the GDUFA III commitment letter released in November 2021. (RELATED: GDUFA III commitment letter details coming changes to FDA’s generic review program, Regulatory Focus 2 November 2021)…
