FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap.

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IT Medical Patient-Centered Provider 69

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. The materials from this webinar are still available on FDAs website ( here ).

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Patient-Centered Consulting Government Clinic 102