Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals: Frequency of Adverse Reactions Observed During Supplemental Approval Compared With First Approval
Conclusions:
Selective data collection should be adopted in cases in which the additional indication of a drug is for the same tumor type and usage as the first or previous indication.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Sekine, N., Ohashi, Y., Aruga, A. Tags: Product Safety Source Type: research
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