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Divergent Global Change Filing Requirements Present Continuous Improvement Roadblocks, Experts Stress at ICH Q10 Conference

The power of the advancing pharmaceutical quality systems to manage change and drive continuous improvement is being hampered by the disharmony and inflexibility of the CMC filing requirements across the globe, prominent industry and regulatory experts reemphasized at a quality systems/ICH Q10 conference in Arlington, Virginia in early October....

FDA Commissioner Outlines Steps to Spur Biomedical Innovation

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EMA Plans Revisions to Influenza Vaccine Guidance

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WHO, USP and PDA Make Substantial Contributions to GDP Guidance Canon

The international pharmaceutical community is continuing to expand and refine its guidance for good distribution practices (GDPs) to give industry the tools it needs to protect and assess product quality in the face of the many hazards of a complex global supply chain....

FDA Releases Draft Guidance on Tablet Scoring

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USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage

The particulate and reactivity issues that have been surfacing involving drugs and biologics in glass containers and the increased interest in polymer alternatives are prompting USP to revise and expand its related compendial standards and guidance....

ICH “Points to Consider” on Implementing Q8-10 Addresses Control Strategy Development and Filing

ICH’s newly-released “Points to Consider” (PTC) on implementing Q8-10 underscores the need for QbD-based marketing applications to provide a scientific justification for the proposed control strategy, including enough information, clearly enough organized, for regulators to understand how the firm developed it....

Control Strategy is Nexus for QbD Regulatory Paradigm, US and EU Regulators Affirm

CMC review policy makers in the US and Europe are focusing increasing attention on the control strategy as the nexus for the advancing pharmaceutical quality-by-design regulatory paradigm....

EMA’s IMP Guideline Will Provide Shelf-Life Flexibility and EU Harmonization

Two key thrusts of EMA’s “Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials” will be to provide flexibility in shelf-life determination for IMPs and to facilitate harmonization of the clinical trial application process across the EU....

FDA May Ask for More Data on Higher Order Protein Structure in Biotech Applications

As methods and technologies designed to unravel the complexities and intricacies of protein folding, three-dimensional structure and function become more reliable and available, FDA is looking at whether it is time to begin requiring more detailed information on higher order protein structure in biotech product applications....
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