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The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...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USA – FDA updates draft guidance on division-level ANDA disputes
The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a...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)...
USA – FDA CGT draft guidance focuses on potency assurance strategy
The US Food and Drug Administration has proposed a guidance that would update its policy on how sponsors can provide information on potency assurance...
USA – FDA adds microbiological assessments to ophthalmic drug quality guidance
The US Food and Drug Administration (FDA) recently issued a revised draft guidance for topical ophthalmic drugs recommending that manufacturers follow certain microbial testing...
USA – FDA issues final guidance on major statement in DTC ads
The US Food and Drug Administration (FDA) last week published a final guidance detailing five standards drug manufacturers should follow to ensure direct-to-consumer (DTC)...
