Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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FDA Licensing Governance Compliance 40

Healthcare Law Blog

AUGUST 25, 2022

Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Negotiation-Eligible Drugs.

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Kaiser Health News

NOVEMBER 27, 2023

These issues are expected to take center stage during the nationally televised 90-minute debate on Fox News, which could have major reverberations for the presidential contest next year and could even help shape the 2028 field of White House contenders. California bans short-term health plans. California Newsom became the first U.S.

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COVID-19 Vaccine COVID-19 Medicaid Medicaid 107

Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. How Nonprofit Hospitals, Health Systems Compensate Executives. Encompass Health’s home health unit attracts acquisition interest-sources. COVID-19 funding is tapped out, HHS says.

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COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40