Regulatory challenges in pharmaceuticals: Navigating global compliance and approval
Keywords:
Drug Repurposing, Cancer Treatment, Regulatory Affairs, Financing Strategies, Intellectual PropertyAbstract
Background _ The concept of repositioning or repurposing existing medicines for new disease indications has emerged as an attractive strategy in drug development. This approach can lead to significant savings in time and financial resources, particularly in the context of cancer treatments, where there is an urgent need for effective therapies. Repurposed medicines often prioritize effectiveness over safety considerations due to the critical nature of cancer care. Aim of Work – This paper aims to provide a comprehensive overview of the strategies employed by drug developers to secure financing, navigate regulatory affairs, and manage intellectual property regulations in order to successfully bring repurposed medicines to market as novel cancer treatments. Methods – The study involved a thorough review of financing options available for repurposing pharmaceuticals, including government grants and charitable organizations. Additionally, it examined historical instances where computer simulations predicted secondary applications of FDA- or EMA-approved therapies, which were subsequently validated through in vitro and in vivo studies. The paper also analyzed the tactics employed by the pharmaceutical industry to address regulatory challenges in bringing these medicines to market.
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