FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). Valentine & Larry J.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. That seems very unlikely to be the case, because exemptions apply only to well-established tests.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

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. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

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Patient-Centered Consulting Government Clinic 102