Bowman Cox
Executive Editor
Latest From Bowman Cox
US FDA’s OPQ Reshapes For More Nimble Approach To Drug Quality Reviews
Reorganization in January expected to leave CDER’s nine-year-old pharmaceutical quality assessment organization more adaptable to public health emergencies, new pharmaceutical technologies and market dynamics, while further blending approaches to new and generic drug reviews.
How Industry Would Reduce The Regulatory Burden For Fleets Of Mobile Manufacturing Units
Stakeholders propose centralized oversight approaches for managing quality of “like-for-like” fleets of self-contained manufacturing units that could roam the US – or the world. The US FDA shares the industry’s thinking on how best to adapt the site-focused regulatory scheme it enforces to the emerging variety of distributed manufacturing systems.
The Quality Lowdown: More Concerns Raised About API Plants, Data Integrity And Sterility Assurance
Recent enforcement activities shed light on compliance challenges at ALI, UCB, Novo, Samsung, Nectar, Panacea and Beximco.
Supply Chain Confidentiality Doesn’t Stand 'Sunshine Test', Califf Says
US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.
US FDA Sets Post-Pandemic Expectations For Manufacturer Remote Interactive Evaluations
Draft guidance outlines how the agency will use RIEs as COVID-19 becomes endemic and agency staff are generally able to travel for site inspections – and how manufacturing facilities should prepare for them.
Supply Chain Confidentiality Doesn’t Stand “Sunshine Test,” Califf Says In Comments On Drug Shortages
US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.