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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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

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. 30, 2023; Public workshop on advancing innovative manufacturing technology, by end of FY 2023; Publish advancing innovative manufacturing technology strategy document, by Sept.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

FEBRUARY 20, 2025

In contrast, AMP and ACLA both asserted that the rule would harm medical care. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) The materials from this webinar are still available on FDAs website ( here ).

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102