Navigating FDA Changes: What Life Sciences Professionals Need to Know The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political [...]

Navigating Regulatory and Patent Challenges in the Combination Products Space The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a [...]

Prepare Your Quality Management System for QMSR Compliance by February 2026 With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for [...]

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, [...]

Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan Insights From Combination Products Summit The journey of developing and commercializing combination drug/device products is [...]

Business continuity planning (BCP) is essential for the success of any enterprise, but it’s particularly crucial for companies in the life sciences industries, where criticality and compliance with FDA regulations may be impacted by a [...]