FDA Law Blog

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. More specifically, the prohibition includes when a “third party (e.g.,

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. Is there any relationship between frailty and urinary incontinence?

IT 120

IT Patient-Centered Patients Clinic 120

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? I love that.

Illness 107

Illness IT Patient-Centered Patients 107