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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 – February 10, 2023

Hall Render

Dunleavy proposes extending Medicaid coverage for new mothers ARIZONA Banner Health pays $1.25M penalty over HIPAA failures from 2016 breach Arizona nursing school at risk of losing accreditation St. billion since pandemic U.S. billion since pandemic U.S. billion since pandemic U.S. billion since pandemic U.S. billion since pandemic U.S.

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

Drug & Device Law

Executive Health Resources, Inc. , 2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Executive Health Resources, Inc. , United States Department of Health and Human Services , 58 F.4th

FDA 105