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Latest From Bowman Cox
When FDA piloted the use of Section 706 authority to obtain records in advance of inspection, the US agency found the results included more inspection findings but not quicker inspections.
As US FDA sets its FY 2018 inspection priorities, it is considering whether there are recent or upcoming inspections by inspectorates in eight European countries recognized under a US/EU mutual recognition agreement that it could rely on instead, agency official says. Over time, FDA could rely more on EU inspection priorities.
Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.
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.