USA – FDA issues QMSR final rule with 2-year transition period
The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a...
USA – FDA: Genome editing therapies may use accelerated approval pathway
The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors developing gene therapy products that incorporate genome editing (GE) of human...
USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary...
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide...
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
USA – FDA final guidances aim to streamline ANDA reviews
The US Food and Drug Administration (FDA) has published two final guidances for generic drug sponsors that the agency says will streamline the premarket...
USA – Growing interest in modeling prompts launch of MIE program for generic drugs
Officials from the US Food and Drug Administration (FDA) explained how sponsors can increase their chances of getting accepted into the new model-integrated evidence...
USA – FDA updates draft guidance on division-level ANDA disputes
The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a...
USA – FDA issues final guidance on rare disease drug development
The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural history and providing...
USA – Novel Drug Approvals for 2023
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of...
USA – Industry groups seek changes to FDA’s remote interactive evaluation guidance
Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration’s (FDA) approach for conducting remote interactive evaluations (RIE)...
