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White Paper

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

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Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of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

Clinic Medical Provider Patients

Does the Drug Shortage White Paper Fall Short?

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

Supply Chain Manufacturing Government Hospital

Primary Care Digest

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

Does the Drug Shortage White Paper Fall Short?

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