Latest Developments and Insights
CMC Safety and Efficacy in Gene and Cell Therapies
Gene and cell therapies are at the forefront of medical breakthroughs, offering new possibilities for treating complex diseases. The success of these therapies heavily relies on the meticulous processes involved in Chemistry, Manufacturing, and Controls (CMC). CMC plays a crucial…
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Accelerating Drug Development: Regulatory Strategies for Fast-Track and Breakthrough Therapy Designations
Bringing innovative therapies to market quickly is critical for treating serious medical conditions, and regulatory programs like the FDA’s Fast-Track and Breakthrough Therapy Designations offer a streamlined path to approval. These pathways allow companies to accelerate development and review by…
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The Evolving Role of Regulatory Affairs in Gene Therapy
As gene therapy continues to evolve, it has the potential to transform medical treatment for a range of complex conditions. Alongside these advancements, the role of regulatory affairs has expanded so that these groundbreaking therapies meet the highest standards of…
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The Evolution of US Biologic Drug Regulations
In the first instalment of our multi-part series, the key differences between biologic drugs and traditional small molecule drugs such as active pharmaceutical ingredient source, molecular size, structural complexity and immunogenicity were introduced. In this second instalment, we explore the…
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Navigating the Evolution from ICH Q2(R1) to ICH Q2(R2) and Implementation of ICH Q14 in Biopharmaceutical Method Validation
In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…
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Regulatory Affairs Compliance Strategies
In today’s highly regulated industries, compliance with regulatory standards is crucial for business success and public safety. Regulatory affairs professionals play a vital role in managing the complex processes involved in meeting these standards, from product development to market approval.…