What's the Regulatory Value of a Target Product Profile?
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DOI: 10.1016/j.tibtech.2017.02.011
Abstract: Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review… read more here.
Keywords: value target; regulatory value; product profile; target ... See more keywords