FDA Law Blog

JANUARY 5, 2023

CDRH is building an extensive library of similar reports and white papers as it prepares its final guidance for medical device cybersecurity, scheduled to come out next Fall. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

OCTOBER 10, 2022

Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of medical information.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

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

FDA Law Blog

JANUARY 24, 2024

Industry should leverage existing technologies while furthering research and development of innovative and disruptive technologies, in partnership with academia and government. A single public entity should coordinate the public-private partnerships established as part of this national strategy.

Supply Chain 69

Supply Chain Manufacturing Government Provider 69

Physician's Weekly

JUNE 12, 2025

More than 10 million people were automatically reenrolled in their coverage for the 2025 plan year, with their eligibility for tax credits confirmed via a system that allows ACA marketplaces to check government or other data sources. The House bill would end that, requiring documentation before receiving tax credits. .”

Insurance 52

Insurance Family Families Government 52