FDA Law

JANUARY 5, 2023

It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

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Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of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. Criterion 4: The fourth criterion seeks to ensure that Non-Device CDS does not supplant an HCP’s independent clinical judgment.

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

FDA Law

JANUARY 24, 2024

That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. Industry should leverage existing technologies while furthering research and development of innovative and disruptive technologies, in partnership with academia and government.

Supply Chain 69

Supply Chain Manufacturing Government Provider 69