Latest From Bowman Cox
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.
Distress grows as manufacturers wait for suppliers to boost production. One idea: stretch inventories by qualifying single-use bioreactors for reuse.
Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.