Featured Insights

  1. Empowering Healthcare Decision-Making 10/21/2024

    FormularyDecisions, now part of Cencora, has evolved significantly since its acquisition in 2019. Let's reflect on its journey, impact, and the future of formulary submissions in the digital age.

  2. The Unintended Consequences Of The Inflation Reduction Act (IRA) 10/21/2024

    Cencora PayerPulse provides insights into market access trends and the Inflation Reduction Act's impact on Medicare Part D, based on research from 41 advisors.

  3. The Use Of Meta-Analytic Predictive Priors In Clinical Trial Design 10/21/2024

    Discover how a Bayesian approach can revolutionize clinical trials by leveraging historical data to reduce sample size, increase power, and make more robust decisions.

  4. Exploring The Journey To eCTD 4.0 10/21/2024

    eCTD 4.0 promises to streamline regulatory submissions and enhance global collaboration. However, implementation challenges and evolving regulatory landscapes pose significant hurdles.

  5. MHRA Provides Details On Windsor Framework For UK Medicines 10/21/2024

    With the Windsor Framework implementation date looming, Northern Ireland will now have its own regulatory authority for medicines. But what does this mean for patients, manufacturers, and distributors?

  6. EMA Raises The Profile Of RWE With Key Reflection Paper 10/21/2024

    As the European Medicines Agency (EMA) finalizes its reflection paper on real-world evidence (RWE), the growing importance of this data source for regulatory decision-making becomes increasingly evident.

  7. The Complex Road To Developing Targeted Therapies 10/3/2024

    Developing targeted therapies is a complex journey, requiring a deep understanding of disease, innovative approaches, and close collaboration with experts.

  8. Regulatory Divergence Presents Barriers To EU Combined Studies 10/3/2024

    EU regulatory divergence creates hurdles for combined studies of medical devices, IVDs, and drugs. The COMBINE project aims to streamline the process and encourage more combined studies in Europe.

  9. Innovative Clinical Trial Designs For Orphan Drug Development 10/3/2024

    Explore how Bayesian methods and innovative trial designs can overcome challenges and streamline the drug development process, enabling faster access to life-changing treatments for rare diseases.

  10. Leveraging The Pharmacological Audit Trail For Clinical Drug Development 10/3/2024

    Discover how the Pharmacological Audit Trail (PhAT), an evidence-based framework, can streamline your drug development process, optimize dose selection, and enhance regulatory success.