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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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Concerted Effort to Define Responsible Use of AI in Healthcare is Sorely Needed

Healthcare IT Today

The following is a guest article by Amy Hester, PhD, RN, BC, FAAN, Chairwoman and CEO at HD Nursing The growing use of artificial intelligence (AI) across a number of industries, particularly in healthcare, has shown both great promise as well as cause for alarm. Government’s AI Executive Order: A Step Forward or Falling Short?

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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

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