Brian Lee

Brian Lee

Alston & Bird

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FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities

Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s first guidance on remote interactive evaluations, a tool in response to the agency’s COVID-19 inspection postponements....more

4/21/2021  /  Food and Drug Administration (FDA) , GAO , Inspections , Manufacturers , Medical Devices , Pharmaceutical Industry

Updates on Biosimilar Reimbursement Pathways in the Face of a Changing Market

Though the biosimilars market has evolved, and more companies are seizing the opportunities, reimbursement regulations have been unclear at best. Our Health Care Group untangles the latest rules from the Centers for Medicare...more

1/25/2018  /  Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Care Providers , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drug Coverage , Prescription Drugs
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