James Boiani

Epstein Becker & Green

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Latest Posts › Manufacturers

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Congress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs

On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which...more

1/20/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs

Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk...

FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides...more

6/29/2020 / Biologics , CGMP , Drug Compounding , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Pharmaceutical Industry , Pharmacies , Regulatory Standards

FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some...more

9/9/2014 / Clinical Laboratories , Food and Drug Administration (FDA) , Laboratory Developed Tests , Manufacturers , Medical Devices , Regulatory Standards

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