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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

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Health Provider News

Hall Render

NATIONAL 4 largest healthcare data breaches of 2023 Anesthesia practices sue CMS over reimbursement method Antitrust enforcements hit a high in 2022, with health deals impacted ASCs face leadership exodus CMS floats appeals process over observational stays CMS proposes additional Medicare appeals processes FTC eyes healthcare mergers, report shows (..)

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Health Provider News

Hall Render

NATIONAL 6 health systems using GPT and AI tools 100,000 nurses left industry during the pandemic, report finds AHA backs bill to delay Medicaid DSH cuts by 2 years AHA launches info hub for healthcare quality leaders AHA opposes MedPAC recommendations to Congress on site-neutral, Part B drug, wage index policies AHA ramps up 340B protection efforts (..)

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Executive Health Resources, Inc. , Executive Health Resources, Inc. , United States Department of Health and Human Services , 58 F.4th In 2023, these include United States ex rel. Polansky v. UnitedHealthcare, Inc. , 3d 239 (Cal. Croda Inc. , 3d 191 (Del. C-8 Personal Injury Litigation , 87 F.4th

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