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 ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

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

MAY 26, 2025

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. FGM is defined as any procedure performed for non-medical reasons. By Andrew J. 116(e) (emphasis added).

Manufacturing 59

Manufacturing Provider Medical IT 59