Europe – Potential risk of neurodevelopmental disorders in children born to men treated with...
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential...
USA – FDA updates draft guidance on division-level ANDA disputes
The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a...
Europe – EMA explains how tweaked Brexit deal will affect medicinal products
The European Medicines Agency (EMA) has answered nine questions on how the revised Brexit rules apply to centrally authorized medicinal products for human use...
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...
International – WHO decision improves children’s access to safer polio vaccine
Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO,...
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USA – FDA CGT draft guidance focuses on potency assurance strategy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The US Food and Drug Administration (FDA) recently issued a revised draft guidance for topical ophthalmic drugs recommending that manufacturers follow certain microbial testing...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)...
