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Latest From Bowman Cox
Puerto Rico's slow recovery from Hurricane Maria provides insight into what happens when disaster strikes a node of the global pharmaceutical manufacturing network. Initial efforts to ward off US drug shortages focus on generic injectables that can't support expensive business continuity plans – but even critical prescription brands could be threatened if the US territory's power grid remains off line too long.
Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.
Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.
It remains uncertain whether a legal review by the European Commission that since June has delayed public consultation of draft ICH Q12 post-approval changes guideline can be resolved during this week's ICH meeting in Geneva.
US drug makers will no longer have to retest batches exported to the EU under a mutual recognition agreement provision expected to take effect by July 2019. It's a landmark development in industry's quest to eliminate import testing, which it says wastes time and resources. But many nations around the world still require import testing – our interactive map shows which rules apply where.
US FDA recognizes the drug regulatory authorities for eight of the European Union's 28 member states by a Nov. 1 deadline, triggering key provisions of the landmark mutual recognition agreement.