Hall Render

JUNE 5, 2024

Stage 2: Effective May 6, 2026 Two years after the Final Rule’s publication, the FDA will expand its regulatory scope to include establishment registration and listing, labeling and investigational use requirements. Part 820), providing added oversight over the quality management of LDTs.

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New Jersey Healthcare Blog

MARCH 8, 2022

For 2023 the healthcare cost growth benchmark is 3.5%, for 2024 3.2%, for 2025 3%, for 2026 2.8%, for 2027 2.8%. 203(a), the Office of the Governor issued Executive Order 280 declaring that a Public Health Emergency, established in Exec Order No. On February 7, 2022, at 54 N.J.R. 103, continues to exist in NJ. 13:34-13.1(d),

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NY Health Law

FEBRUARY 13, 2024

That application, which is the successor to the state’s Delivery System Reform Incentive Payment (DSRIP) Program that expired in March 2020, was first described in a concept paper issued by the Department of Health (DOH) in August 2021, and was filed with CMS in September 2022.

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SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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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. Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to 30 days.

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SQA

FEBRUARY 15, 2023

ICMRA recognizes that AMR is a complex, multifaceted problem and calls for better coordination across all sectors, including public health, animal health, and the environment, through a ‘One Health’ approach. Tackling AMR is one of ICMRA’s strategic priorities.

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Healthcare Law Blog

AUGUST 25, 2022

After 2026, the timing for publication is standardized – the February 1 st two years prior to the price applicability date will be the drug publication date. Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. Negotiation-Eligible Drugs.

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