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Injectable combination product development: facilitating risk based assessments for efficiency and patient centric outcomes

Published in J. Pharmaceutical Sciences, April 2020. F. DeGrazio, D. Paskiet
Combination products continue to be on the rise, from the innovation of novel medicines and greater demand for injectable home and self-administration. Qualification will depend upon the regulatory jurisdiction with reference to the product’s primary mode of action; to facilitate this, a consult or collaborative review process involving different centers within the FDA may be necessary

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