FDA Law Blog

SEPTEMBER 20, 2021

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. The endpoints must be novel (i.e.

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The Medical Futurist

MAY 18, 2025

By 2027, global surgical robotics sales are expected to reach $14.8 A human-sized, smiling robot combines the very best in cutting-edge technology and human touch to provide frequent check-ins and non-medical care for residents in long-term care settings. The waiting lists can be long depending on available manpower and resources.

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FDA Law Blog

JULY 24, 2023

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.

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FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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