FDA Law

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

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 Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

Physician's Practice

JUNE 9, 2025

68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

Management 52

Management Telemedicine Insurance Patients 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. And so often we get consulted by teams that say, “I have this older patient and they’re pretty isolated and I think they have dementia. So they’re left out.

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. And that’s a good thing to share with an older patient or client that making decisions about your activity.

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). If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. Dr. Maisel also discussed disposition of already distributed devices.

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59