Posts Tagged ‘FDA trends’

Your Guide to the 2024 Combination Products Summit: Agenda, Insights, and What to Anticipate

Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination Products Summit is the premier event where industry leaders, regulators, and experts come together to tackle these challenges head-on.

This year’s summit promises to be more impactful than ever, offering a comprehensive agenda that will equip professionals with the knowledge and tools they need to navigate the complexities of combination products in a dynamic regulatory environment.

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ComplyFDA Presents: Baseline Assessment

Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments

Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to ensure robust solutions. I found this analysis extremely insightful and wanted to share it with you: Read more »