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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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From Surgeries To Keeping Company: The Place Of Robots In Healthcare

The Medical Futurist

By 2027, global surgical robotics sales are expected to reach $14.8 Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. Robotic medical dispenser systems, medication management solutions help any given facility “right-size” its system for its volume.

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“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law

According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving. Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.