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Several countries have therefore produced policies aimed at encouraging pharmaceutical and biotechnological companies to develop innovative drugs that are in serious demand in the society. An example of this policy is the Orphan Drug Act which offers exclusive marketing rights, grant support, tax credits for certain clinical development expenses and other incentives for sponsors to develop drugs for rare diseases .
The objective of this paper is to describe the regulatory frameworks pertinent, though not necessarily specific to monoclonal antibodies Gemtuzumab Ozogamicin (“Gemtuzumab” or “Mylotarg”) and to outlined the key regulatory and compliance aspects for drug development and dissemination.
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