FDA Law

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. We can offer our readers a special discount for the event.

Management 59

Management Manufacturing Specialization Government 59

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

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. is it the lab itself, the healthcare provider, or the patient?).

Manufacturing 64

Manufacturing Electronics Provider Management 64

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.

Management 52

Management Telemedicine Insurance Patients 52

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

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