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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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Healthcare IT Today

JANUARY 19, 2024

Similarly, unlike previous upsurges, this momentum feels more mature – less about experimentation and ‘shiny objects’, more about real-world applications at scale. are expected to reach $6 trillion by 2027, cost containment and the push to increased decentralization of care will be a top healthcare priority in 2024.

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SQA

MAY 24, 2023

Public Advisory: Robikids and Solmux are Unauthorized Syrups for Thinning Mucus and May Pose Serious Health Risks, 03 March 2023 Health Canada is warning parents and caregivers about two unauthorized children’s syrups for thinning mucus, Robikids and Solmux, seized from Kamshoppe, which advertised the products on Facebook.

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Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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Hall Render

OCTOBER 27, 2023

Ransomware attacks against hospitals put patients’ lives at risk, researchers say States, FTC continue to target noncompetes: 3 updates The best hospital in each state, per Newsweek What to know about Stark law’s $9.2M with historic building purchase MICHIGAN Bronson raises capital campaign goal to $4.5M

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Hall Render

NOVEMBER 17, 2023

Grifols gets FDA approval for new facility in Clayton Invitae pledged $115M, 374-job investment in North Carolina. Million Individuals Affected by MOVEit Hack MARYLAND Adventist HealthCare, Montgomery College form partnership to address need for qualified nursing workforce Harford Memorial Hospital closing set for Feb.

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