FDA Law

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. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time.

IT 102

IT Screening Hospital Clinic 102

GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. 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? So when they do meet it, how are you going to be in relationship to it? James, welcome to the GeriPal Podcast.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. What do we do to very concretely provide heat shelters and cool shelters? And there are so many things that can be done to address climate change.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical 59

Medical Manufacturing Patient-Centered Provider 59