FDA Law

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Instead, the exemption from the NTL criteria now applies to an individual food, or a mixed product that is comprised of one or more of the foods recommended by the DGs (i.e.,

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Individual Manufacturing Provider IT 52

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance. The FDA webinar information can be found here.

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Patients Clinic Medical Patient-Centered 52

FDA Law

SEPTEMBER 20, 2021

When travel restrictions and public health precautions halt facilities inspections, many sponsors are left wondering how FDA will complete pre-approval inspections and meet their products’ respective PDUFA dates. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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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. By Andrew J. Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. Genentech, Inc.,

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Manufacturing Provider Medical IT 59