Halloran Insights

  1. Hiring Your Head Of Quality - Borrow Or Build? 8/11/2025

    Leaning on an interim Head of Quality offers advantages during the search for a full-time hire, such as flexibility and access to seasoned expertise for startups.

  2. Key Takeaways From Halloran's CORE Program: Advice For Clinical Leaders 8/11/2025

    Explore the strategic use of user-friendly digital systems to enhance participant engagement and reduce errors, thereby prioritizing a culture of quality over error tolerance.

  3. Enhancing Readiness For FDA's Expanded Foreign Inspection Program 7/10/2025

    Learn about the FDA’s expanded, unannounced inspection program for foreign manufacturing sites that aims to align oversight of global pharmaceutical and medical device production with domestic GMP standards.

  4. Understanding The Commissioner's National Priority Voucher 7/10/2025

    The Commissioner's National Priority Voucher (CNPV) reflects the FDA’s focus on modernizing review processes, integrating AI and non-animal models, and bringing treatments to patients faster.

  5. ICH E6(R3) And A Risk-Based Approach As A Competitive Advantage  6/5/2025

    ICH E6 (R3) advocates for a streamlined, risk-informed trial design that enhances quality and participant experience, paving the way for more efficient and successful clinical research outcomes.

  6. Halloran's Regulatory Lens – What We're Watching In 2025 6/5/2025

    As the regulatory environment evolves in 2025, product developers face increasing complexity driven by external pressures such as tariffs and internal shifts like FDA personnel changes.

  7. Risk Mitigation Planning For Pharmaceutical Tariffs 5/7/2025

    Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.

  8. Ticking Timeline: Tips For Effective Product Development Timelines 4/21/2025

    Biotech and pharmaceutical companies must establish clear product development objectives and well-designed timeline to navigate the drug development lifecycle effectively.

  9. How The FDA Is Phasing Out Animal Testing Requirement 4/21/2025

    The FDA is embarking on a transformative initiative to phase out animal testing requirements.

  10. Key Update On Guideline For Good Clinical Practice E6(R3) 4/21/2025

    Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.