The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) program. The guidances revise ones issued under GDUFA II and clarify how the agency plans to hold up its end of the new user fee deal, which covers FY 2023 to FY 2017.
FDA updated a 2020 guidance on how it designates products as competitive generic therapies (CGT) to expedite certain generic products to market. The updated guidance outlines expectations for abbreviated new drug applications that receive CGT designation which qualify them for mid-cycle review meetings (MCRM) and enhanced mid-cycle review meetings (EMCRM).
“Applicants of an ANDA for a drug product designated as a CGT may be eligible to request a mid-cycle review meeting (MCRM) during the first assessment cycle,” FDA states. “Applicants of an ANDA for a complex product (including complex drug products designated as a CGT) may be eligible to request an enhanced mid-cycle review meeting (EMCRM).”…
