FDA seeks to streamline biosimilar approvals

Generic drugs don't need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines.

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Top Story FDA Proposes Dropping Clinical Trial Requirements to Bring Biosimilars to Market More Quickly Generic drugs don't need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines. Sponsored RCM Outsourcing: Balancing Human Expertise & Smart Technology Presented by Greenway Health Greenway Health blends smart technology with human expertise to elevate revenue cycle. Learn More.

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Samsung Health, HealthTap Launch Virtual Primary Care Partnership HealthTap and Samsung Health have partnered to offer virtual primary and urgent care within the Samsung Health app. Mayo Clinic-Backed Corvus Launches to Fix the Surgical Referrals Process Corvus, a Chicago-based startup aiming to simplify the surgical referrals process, announced its launch. The company's AI platform helps healthcare teams manage inbound surgical referrals more efficiently, ensuring patients are routed to the right treatment while also optimizing operating room utilization. DPC Physicians Are Running Blind Without Clinical Data Real-time access to clinical data would reduce the wasted time and effort tracking down referral records and enable a more proactive, rather than reactive, approach to patient treatment plans.   The Next Phase of Surgical Robotics Technology advancements like imaging will overlap with changing commercialization models and new hospital realities to enable entirely new patient impacts and economic models.

Video   Virtual OUD Treatment Is Proving Valuable A report from the Peterson Health Technology Institute found that virtual opioid use disorder companies are just as effective as standard in-person treatment — and they can improve retention. For a long time, the OUD treatment community believed that care needed to be delivered in person, noted Caroline Pearson, an executive director at Peterson Health Technology Institute. However, particularly since the pandemic, virtual care has proven to be effective and convenient, especially in place where there aren't many providers.

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Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care Choosing the wrong EMR can slow your practice down. This guide helps healthcare teams compare options, avoid costly pitfalls, and choose a platform that improves care, compliance, and patient experience. View Now

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