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Temporary COVID-19 Policies Becoming Permanent

USA - January 26 2021 On Jan. 15, 2021, the U.S. Department of Health & Human Services (HHS) issued a notice, “Making Permanent Regulatory Flexibilities Provided During…

Lee H. Rosebush, Marc N. Wagner

HHS Issues Advisory Opinion on Contract Pharmacies Under the 340B Program

USA - January 11 2021 On Dec.30, 2020, the Department of Health and Human Services (HHS) Office of the General Counsel released an Advisory Opinion concluding that drug…

Lee H. Rosebush, Marc N. Wagner

COVID-19 Vaccine: Approval or Authorization?

USA - December 15 2020 On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the…

Lee H. Rosebush, Marc N. Wagner

Supreme Court Gives Nod to States Regulating Pharmacy Benefit Managers Reimbursement

USA - December 11 2020 On Dec. 10, the United States Supreme Court issued its ruling in Rutledge v. Pharmaceutical Care Management Association. The Court reversed the 8th…

Lee H. Rosebush, Marc N. Wagner

FDA and Pharmacy Weekly Digest - October 8, 2020

USA - October 8 2020 The United States Food and Drug Administration (FDA) is proposing to establish additional…

Lee H. Rosebush, Lance L. Shea, Marc N. Wagner