FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59