Healthcare Law Blog

MARCH 17, 2022

On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented.

US Department of Health and Human Services 52

US Department of Health and Human Services Informed Consent Medicare Medicare 52

SQA

FEBRUARY 15, 2023

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.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Drug & Device Law

DECEMBER 29, 2023

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

FDA US Department of Health and Human Services COVID-19 Informed Consent 105