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Insights & Intel

Life science observations from inside the industry

Explore “Insights & Intel,” the Bracken blog. Our team of life science experts is laser focused on the news and evolution of the industry, from marketing trends to actionable interpretation of the latest regulatory guidances. Discover the latest from Bracken.

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    What to Do if Your IND Is Placed on Clinical Hold
    Regulatory

    featured blog post

    What to Do if Your IND Is Placed on Clinical Hold

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    Regulatory
    What to Do if Your IND Is Placed on Clinical Hold
    Bracken
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    Regulatory
    Keeping Pace with Regulatory Change: Key FDA Updates in Early 2025
    Bracken
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    Regulatory
    Optimizing Written and Face-to-Face Communications with the FDA
    Bracken
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    Regulatory
    FDA Sunsets Rare Pediatric Disease Program: Critical Updates for 2024
    Bracken
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    Regulatory
    The Patient Voice in Cancer Treatment: Unpacking FDA’s Game-Changing Guidelines
    Martin Collyer, MSc, FCCA
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    Regulatory
    The Crucial End of Phase 2 FDA Meeting: A Drug Development Milestone
    Bracken
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    Regulatory
    Navigating FDA's New Benefit-Risk Assessment Guidance for New Drug and Biological Products
    Martin Collyer, MSc, FCCA
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    Regulatory
    A Path Forward: The Journey to Orphan Drug Destination
    Bracken
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    Regulatory
    The Path to FDA Approval: When to Consider a Pre-IND Meeting
    Bracken
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    News Regulatory
    FDA's New Guidance on Formal PDUFA Products
    Bracken
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    News Regulatory
    Learn About FDA's New Informed Consent Guidance
    Bracken
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    Regulatory
    Regulatory Affairs CMC—Don't Go it Alone
    Bracken
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