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    Innovation Leads to Transformation in Regulatory Agencies' Evaluation of Benefit-Risk

    Several innovations are currently being discussed or implemented by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). One key innovation area is the assessment of a medicinal products benefit-risk. A major focus is assessment of whether drug, device and biologic products have an appropriate benefit-risk balance for marketing approval and continued marketing. Recent International Conference on Harmonisation (ICH) guidelines, European legi...
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    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...