article thumbnail

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 With Teladoc , Doctor on Demand , Health Tap , or American Well patients in remote areas have access to high-quality emergency consultations for stroke, cardiovascular, dermatological problems, or any other complaints. But there is undoubtedly impressive progress.

article thumbnail

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

FDA Law Blog

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027. Though the Orphan Drug Act (now) includes a clinical superiority clause, Jazz argues that it is not a third exception to ODE. .

Clinic 52
article thumbnail

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

FDA Law Blog

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. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027). up to 125 total products enrolled through FY 2025).