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. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

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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Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of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. Interpretation of Statutory Criteria Under the Final Guidance.

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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.

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Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

JANUARY 24, 2024

As discussed in the new report, producing 25% of all APIs for small molecule drugs within 5 years is an achievable goal: To achieve this goal, this white paper proposes API manufacturers adopt advanced manufacturing technologies provisioned through public incentives. bioeconomy.” The first goal under Theme 1—Goal 1.1—is

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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. It passed the House on May 22 and is pending in the Senate.

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