Regulatory change is a constant in early drug development. In recent years, expectations are now more clearly articulated, particularly in areas such as bioanalysis and advanced modalities.
The regulatory landscape is becoming more predictable with advancements, like ICH M10, clearer biomarker validation frameworks, and SEND compliance requirements. Regulators increasingly expect scientific justifications to be built into the initial submission instead of negotiated later. These are not obstacles, but rather a roadmap for development. By integrating regulatory foresight into your earliest study designs, you eliminate the risk of repeated filings, addressing avoidable program inefficiencies before they arise.
Below, we explore common pitfalls of poor…
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Source www.biospace.com
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