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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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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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