FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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. More specifically, the prohibition includes when a “third party (e.g.,

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

Physician's Practice

JUNE 9, 2025

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. Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information. Adler, J.D.,

Management 52

Management Telemedicine Insurance Patients 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. And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia.

IT 102

IT Screening Hospital Clinic 102

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. What do we do to very concretely provide heat shelters and cool shelters?

Healthcare 128

Healthcare IT Education Community 128

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.

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59