Posted 01 February 2017
By Linda Bowen, MS, RAC, João Duarte, MPharm
This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities.
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Categories: Biologics and biotechnology, Drugs, Clinical, Labeling, Regulatory strategy, Submission and registration, Features, US, Europe, FDA, EMA