USP Monographs Take Time, Depend On Manufacturers
Biologics, because of their complexity, can lengthen an already long process, USP says.
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CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
A deputy center director position remains open and four new associate director positions were added over the last year.
As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.