FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

Manufacturing 52

Manufacturing IT Relationship Medical 52

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.

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Adler, J.D.,

Management 52

Management Telemedicine Patients Insurance 52

GeriPal

MAY 5, 2022

And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia. One thing we’ve looked at a little bit, but it has not been well studied is the accumulation of ototoxic medications. Five big manufacturers.

IT 102

IT Screening Hospital Clinic 102

FDA Law

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications.

Healthcare 128

Healthcare IT Education Community 128